CN103974670A

CN103974670A - Catheter system for vessel wall injection and perivascular renal denervation

Info

Publication number: CN103974670A
Application number: CN201280051666.9A
Authority: CN
Inventors: 大卫·R·菲谢尔; 蒂姆·A·菲谢尔
Original assignee: Ablation System Co Ltd
Current assignee: Ablation System Co Ltd; Ablative Solutions Inc
Priority date: 2011-08-24
Filing date: 2012-08-22
Publication date: 2014-08-06
Anticipated expiration: 2032-08-22
Also published as: HK1202399A1; SG11201400138YA; JP6932037B2; US10576246B2; EP2747688B1; US20130053792A1; CN107899126B; JP2017205577A; US20190117936A9; US20140358079A1; US20180193596A1; US11752303B2; EP2747688A4; CN107899126A; WO2013028781A1; JP6266516B2; US20240033479A1; US20200197663A1; JP2014524342A; EP2747688A1

Abstract

A catheter-basedAintravascular ablation (denervation) system includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic or/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable needle delivery system is formed with self-expanding materials and includes structures, near the end portion of the needles, or using separate guide tubes. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

Description

For the conduit system of blood vessel wall injection and all kidney denervations of blood vessel

Cross reference with related application

The application requires the Application No. 13/216,495 of submitting on August 24th, 2011 and the priority of Application No. 13/294,439 of submitting on November 11st, 2011, and described patent application is incorporated in this entirety separately by reference.

Technical field

The application melts the device field that myocyte and nerve fiber are used for the treatment of arrhythmia, hypertension, congestive heart failure and other obstacles.

Background technology

Since nineteen thirties, near known orthosympathetic damage in renal artery skin or renal artery skin or melt and can sharply reduce hypertension.As far back as nineteen fifty-two, ethanol is for zoopery.Particularly, Robert M.Berne is at " Hemodynamics and Sodium Excretion of Denervated Kidney inAnesthetized and Unanesthetized Dog " Am J Physiol, October1952171:(1) describe in 148-158 and smeared ethanol in the arteriorenal outside of dog to produce denervation.

At present, doctor uses radio frequency (RF) conduit system to melt the conducting tissue in the heart left atrial wall around orifices of pulmonary veins conventionally, treats (AF) patient that suffers from atrial fibrillation.Use the similar technique of radio-frequency (RF) energy successfully for renal artery inside, to melt sympathetic nerve and other nerve fibers moved in renal artery outer wall, so that treatment hypertension.In both cases, these are conduit systems of meticulous costliness, and described conduit system can cause that heat, cryoablation or additive method are with damage peripheral tissues.Many remarkable Capital expenditures that also need for reusable equipment in these systems, described reusable equipment is positioned at health outside, comprises RF generation system and the fluid handling system for cryoablation conduit.

Because anatomical similarity, for object of the present disclosure, term target wall refers to or herein near pulmonary vein wall orifices of pulmonary veins of AF ablation applications, or for the renal artery wall of hypertension or congestive heart failure (CHF) application.

In the situation that atrial fibrillation is melted, can be technical challenge and very consuming time around multiple pulmonary venous ablation of tissue.If use the RF conduit that once only can melt a focus, particularly like this.The mortality that also exists the conduit that uses these types to melt for atrial fibrillation.The failure of method at present relates to the challenge in the repeatability circumferential ablation of (mouthful week) tissue around generation orifices of pulmonary veins.Also exist and the current remarkable safety problem of technology, described current technology relates to extremely long fluoroscopy and operating time, and this causes patient and operator's high levels of radiation to expose, and can increase the risk of stroke of atrial fibrillation in melting.

Use the current technology melting for RF from the inner sympathetic nerve denervation that produces of renal artery, be used for the treatment of hypertension or congestive heart failure, also have potential danger.The short-term complication and the long-term sequela that from renal artery inside, RF energy are applied to arterial wall fully do not limit.This class energy applying in renal artery and the saturating wall injury of renal artery of following can cause restenosis in late period, thrombosis, renal artery spasm, at the intraparenchymatous fragment thromboembolism of kidney or at the other problems of renal artery inside.If particularly there is anatomic abnormalities or atherosclerosis or fibrotic disease in renal artery inside, also can exist inhomogeneous or incomplete sympathetic nerve to melt, make to exist the inhomogeneous of RF energy to send.This can cause treating unsuccessfully or needs are other and the RF energy of danger level, to melt the nerve of membrane plane operation outside renal artery.

The Ardian system of sending for RF energy does not allow effective circumferential ablation of kidney sympathetic fiber yet.If circumference RF energy is put on from (the energy applying at intimal surface place of the circular segments in renal artery, to kill the nerve in adventitia skin), this can cause the even higher renal artery stenosis danger from the circumference to inner membrance, middle film and adventitia and saturating wall hot injury.Finally, the renal artery inside " burn " that uses RF to melt can be extreme pain.Therefore, there are numerous and a large amount of limitation of the current method that uses the kidney sympathetic nerve denervation based on RF.Similar limitation is applicable to ultrasonic or other energy delivery techniques.

By people such as Seward at U.S. Patent number 6,547, the Bullfrog describing in 803 and 7,666,163 micro-infusion catheter uses inflatable elastic air bag so that single needle is expanded for blood vessel wall, can be used for injected chemical and melt such as ethanol of solution, but it need to repeatedly apply, because it is not described or expects that melting the circumference of material around the whole circumference of blood vessel sends.The most of pin numbers that shown by Seward are two, and Bullfrog two aciculiform formulas will be difficult to miniaturization, to coordinate through the little guide catheter for the treatment of to use in renal artery.If only use a pin, any device is also difficult in control and the accurate rotation at catheter tip place at most, and if follow-up injection is not evenly spaced, can be dangerous.This device also do not allow nerve melt reagent accurately, the sending of control and adjustable-depth.This device also can have the physical constraint about spendable pin length, thereby reagent is expelled to the ability especially with the enough degree of depth in the ill renal artery that thickens inner membrance by restriction.Bullfrog another limitation be that the inflation of air bag in renal artery can be induced narrowly due to the air bag damage of endarterium and middle film, and cause that endotheliocyte strips off.

Jacobson and Davis be at U.S. Patent number 6,302, described the conduit being used for injecting medication in blood vessel in 870.Although Jacobson comprises the concept of abducent many pins, each root in described pin all has handle with penetrating in restriction pin intravasation wall, and his design dependency has the rotation of the pipe of pin at its far-end, to allow it to obtain bandy shape.Show that the handle design having for the attached shallow bid of needle distal nearside short distance has fixed diameter, described fixed diameter makes overall apparatus diameter be increased at least twice of shank diameter, make as enough greatly to stop penetrating of pin in diameter in fruit stem, its significantly increases diameter of device.For kidney denervation or atrial fibrillation application, the length of required conduit will make this type of Spin Control difficulty.In addition, the handle that penetrates of restriction is and the fixed range of needle distal.There is not the member of the adjustment to penetration depth, if wish the certain layer in selectivity target vascular therapy, if or need to penetrate the volume of the tunica adventitia through thering is different wall degree always, this can be important.Jacobson does not also imagine the purposes of injection catheter for denervation.Finally, in Fig. 3 of Jacobson, in the time that he is presented at the sheath that can expand on pin, do not exist wire and sheath to have open distal end, this makes through the propelling of vascular system more difficult.In addition,, if pin is extracted out from sheath is inner completely, they are released because handle can become to be stuck in sheath and to be difficult to.

Prior art is not also imagined the use of for example lignocaine of anesthetis, if first injection or melting in solution injection or inject together with melting solution, described anesthetis can reduce or eliminate any pain relevant to denervation operation.

As far back as 1980, as by people such as Kline at " Functional re-innervation and development ofsupersensitivity to NE after renal denervation in rats ", American Physiological Society1980:0363-6110/80/0000-0000801.25, disclosed in R353-R358 page, ethanol has been presented at and provides kidney denervation aspect in animal model is effective.Although Kline in nineteen eighty-three at paper " Effect of renaldenervation on arterial pressure in rats with aortic nerve transaction " Hypertension, 1983, statement again in 5:468-475: " 95% ethanol is applied to blood vessel to destroy any residue nerve fiber, use this technology for kidney denervation, we have found to exceed 90% depleted (being <10mg/g tissue) in latter 4 days kidney NE concentration of operation ", but Kline be again disclosed in 95% alcoholic solution of applying in operation process in rat, melt around arteriorenal be effective aspect neural.Although drug delivery tube is for example designed to inject a fluid into the conduit in arterial wall at multiple somes place by Jacobson, since nineteen nineties, exist, and ethanol is effective as the treatment element for kidney denervation, still there are the needs of intravascular injection system, described intravascular injection system specialized designs, for the blood vessel week circumferential ablation of the sympathetic fiber of the skin around renal artery, has adjustable penetration depth to adapt to the transmutability in renal artery wall thickness.

McGuckin is at U.S. Patent number 7,087, described in 040 and had three the tumor tissues ablation catheters that can expand tooth, and the described tooth of expanding is for injecting the fluid that leaves single needle.Teeth directional external expansion is to penetrate tissue.McGuckin device has open distal end, and it does not provide the protection not being subject to from the involuntary acupuncture of pointed tooth.In addition, McGuckin device relies on the pointed tooth with sufficient intensity, makes them and to penetrate tissue to external expansion.In order to realize this type of intensity, tooth will not be enough little, so that while retracting after the fluid injecting for kidney denervation application, have negligible losing blood.Also do not have the exercisable limiting mechanism that penetrates, it arranges reliably from the injection of tooth and exports the penetration depth with respect to blood vessel, does not also have the preset adjustment about this type of degree of depth.For the application for the treatment of liver tumor, continue adjustable tooth penetration depth meaningful in the time of multiple injection that may be in several degree of depth; But, for kidney denervation, can in the degree of depth, precision tuning be crucial, so that it is too shallow and kill arteriorenal middle film will not melt fluid infusion, maybe will melt fluid infusion too dark and miss just in time or nerve in renal artery skin outside at renal artery.

Finally, the people such as Fischell are at U.S. Patent application 13/092,363, have described in 13/092,363 and have had the extendible catheter in blood vessel that can expand needle injection.In 13/092,363, Fischells discloses the catheter in blood vessel with sheath, different from Jacobson, and described catheter in blood vessel has the configuration of closing that encapsulates prong completely, with the pathogen of protecting medical personnel not propagated by needle stick injuries and blood.But Fischell application 13/092,363,13/092,363 only shows that operation enters in the left atrial wall around orifices of pulmonary veins or enters in renal artery ostium aorta wall around and the design not entering from internal blood vessel.

Summary of the invention

In the application's blood vessel, neural ablation system (INAS) can apply and melt fluid, use disposable conduit and do not need other fixing device, follow relatively short treatment time, near the nervous tissue in blood vessel wall or blood vessel wall, produce circumference damage.The principal focal point that INAS uses is in the treatment of arrhythmia, hypertension and congestive heart failure.Different from Bullfrog or the RF ablating device with one or maximum two ablation points work, the present invention be designed to provide blood vessel week fluid injecting, allow the more even circumference damage to nerve, make inner membrance to blood vessel wall and the damage of middle rete drop to minimum simultaneously.Term circumference is sent to be defined as herein and is suitablely melted solution injection at least three points in blood vessel wall, or fills at the circumference in the outside space of tunica adventitia layer (outer wall).With the Jacobson device difference of really describing the U.S. Patent number 6,302,870 that circumference sends, the present invention does not rely on the rotation of pipe to produce outside movement, and it does not have fixed diameter handle yet and penetrates with restriction.In addition, although Jacobson shows the form that his device retracts in sheath sample pipe, but pipe has open end, and Jacobson requires to need increase in diameter to adapt to manifold, and described manifold allows fluid flowing from the near-end of conduit to a chamber by many pins outlets.The preferred embodiments of the present invention are used the manifold coordinating in tube chamber, therefore greatly reduce conduit diameter, and this strengthens conduit sending the desired area in human body.

Particularly, there are the definite needs about this type of conduit system, described conduit system can highly effectively and melt the nerve around renal artery ostium in repeatability blood vessel week, or in renal artery wall mouth distally nerve, so that infringement traces into the sympathetic fiber in renal artery from all aorta walls of mouth, and therefore improves hypertensive control and treatment etc.

By allow highly effectively and repeatability blood vessel week circumferential ablation enter near muscle fiber and the conductivity left atrium inherence orifices of pulmonary veins of heart or in the pulmonary vein wall at orifices of pulmonary veins place, this type systematic also can have the main advantages that exceedes other current technology.This type of melts and can interrupt atrial fibrillation (AF) and other arrhythmias.Other potential application of this method of can evolving out.

The present invention is little (<2mm diameter) conduit, and it is included in its far-end and has multiple syringes of expanding of sharp-pointed entry needle.Preferred embodiment also comprises extendible guiding tube, to guide the process of coaxial syringe, to be conducive to the penetrating of sharp-pointed entry needle of circumferential arrangement around near the INAS main body its far-end.Melt fluid and can pass through the distal injection of these pins, each root in described pin has in its far-end or near the outlet of the injection its far-end.There is the limiting member that penetrates as INAS part, pin will only be penetrated in the tissue of target vessel wall to preset distance.These can be the preset distance for every needle distal nearside, are similar to the handle of people's patents such as Jacobson, or penetrate in the proximal section that limiting member can be building up to INAS.Restriction penetrate for following be important: reduce the probability of blood vessel wall perforation, the degree of depth of the blood vessel Zhou Tiji that the degree of depth of optimization injection or adjustment enter just in time in blood vessel wall outside.For PVRD(blood vessel week kidney denervation) preferred embodiment, first extendible guiding tube launches for renal artery inwall, and serve as the guiding about the coaxial longitudinal removable syringe separating, described syringe has sharp-pointed entry needle, and described entry needle has near one or more injection outlet ports far-end.

Ideally, entry needle should be enough little, after making to extract out after penetrating by renal artery wall completely, do not exist and lose blood.The main advantages of the embodiment of the present invention is to have this type of little (<25 specification) pin, can be quite fragile from expansion structure, and for guaranteeing that accurately penetrating of blood vessel wall is insecure.The present invention addresses this problem in 2 kinds of modes.Use restriction at the attached rope in the fixed range place for needle distal nearside or line penetrates, and extendible entry needle is connected to each other, and helps to produce the even expansion of entry needle, to be conducive to reliably penetrating of blood vessel wall.But preferred embodiment is the use of extendible guiding tube, described guiding tube is opened for internal blood vessel, and the point of entrance of the blood vessel wall that therefore every entry needle directly led.Guiding tube can be made up of for example NITINOL of memory metal or for example polyamide of plastic material or polyurethane.Guiding tube should be also radiopaque or have radiopaque labelling at tip place, for example tantalum, gold or platinum band.The ideal configuration of guiding tube is have soft tip preformed from expansion plastic tube, to do not damage or accidentally penetrate in blood vessel wall.The last 0.5-3mm of this plastic tube can form in the filled plastics with for example barium of radiopaque material or tungsten.Also imagine for example polyurethane on outside of two layers of plastic pipe and the polyamide on inside even better structure can be provided.The hardness of plastics using also can change with following: at the soft material at tip place, and the more hard material in bending and abducent part and again at the more soft material for expanding in the section of section nearside.This softer last section by be conducive to INAS around almost right angle turn of bilge by entering sending of guide catheter in renal artery.

Stop for target vessel inwall in order to be conducive to guiding tube, imagination has formation the distal part of the syringe of the radius of curvature almost identical with guiding tube, and described distal part comprises entry needle.In fact, the radius of curvature of guiding tube will change with blood vessel diameter, larger for less blood vessel, and described less blood vessel, by confinement tube, does not allow them to open completely.Therefore, ideally, each syringe comprises that the radius of curvature of the distal part of entry needle should be identical at its maximum gauge place with the distal part of guiding tube.

Term is extendible will be used everywhere in this description, to describe the outside movement of a part of the present invention with respect to the longitudinal axis of INAS conduit.It comprises the outside motion of guiding tube, syringe and/or pin.This expansion can carry out the expansion certainly from expansion structure discharging since restraining structure, or it can be the expansion for example, promoting by distally or the proximal movement of another mechanism in INAS (line that promotes or pull expandable structure to leave from longitudinal axis).Can be used for describing this another term outwards moving is that term can depart from.For example, outwards depart from when from its restraint release from expansion structure, and the use that distally or nearside move the line that causes the outside movement that can depart from parts will be the structure that available hands departs from.Also imagining aerating gasbag can be used for outwards departing from or expanding and can depart from or expandable structure from the longitudinal axis of INAS.

The preferred embodiments of the present invention that work in the blood vessel of different inner diameters are had to guiding tube and entry needle, and described entry needle has the far-end of syringe of curved shape.Ideally, the expanded configuration of guiding tube will arrange like this, if make not have the constraint of internal blood vessel, they are slightly larger than by reaching the expansion diameter of imagining the maximum blood vessel for installing use.Guiding tube shape also should have the far-end that adds or deduct 30 degree places at longitudinal axis 90 degree for INAS.For example, INAS guiding tube can have free 9mm diameter, wherein far-end bending 100 degree backward, vertically 10 degree backward also of the longitudinal axis that is compared to INAS.Therefore,, in the time retraining in 8mm or less tremulous pulse, the angle that guiding tube engages internal blood vessel thereon will be less than 100 degree.For example, in 7mm diameter blood vessel, the distal tip of guiding tube can be close to 90 degree, can be close to 80 degree in 6mm blood vessel, and can be close to 70 degree in 5mm blood vessel.Even in 5mm blood vessel, due to the curved shape of entry needle, this system will be worked, and described entry needle is bending backward by the near-end for INAS, and guarantees suitably penetrating of blood vessel wall.Key character of the present invention is that they are bending backward in proximal direction when syringe is from guiding tube remote extension and while penetrating by blood vessel wall.It is typical having expanded position in the injection outlet of every entry needle of syringe far-end, and described expanded position is at the nearside of guiding tube far-end.For example, export for the entry needle injection of the far-end 2.5mm distance exceeding guiding tube, injection outlet can be at the nearside 1-2mm of guiding tube far-end.

Because accurately the degree of depth to penetrate be preferred, institute should have limited draftability for pipeline any in INAS nearside or distal section, and they are not elongated in expansion enters the process in renal artery by guide catheter.For example, rustless steel, L605 or NINTINOL can be the optimal materials for the proximal section of INAS.The metal strengthening pipeline with minimizing elongation trend can be the distal section the best for INAS, needs more elasticity in described distal section, with mobile around almost right angle turn of bilge from aorta to arteriorenal guide catheter.

The limitation function that penetrates of INAS of the present invention uses one of following technology as described herein, with U.S. Patent number 6,302,870 Jacobson design is compared, described technology will greatly reduce the diameter of device, and therefore also improves for example ability in renal artery of human vas that is delivered to.These technology comprise:

Be attached to the use of rope or the line of many pins, described rope or line can fold during insertion, to limit the diameter of distal section of INAS,

Be attached to the use of one, two or more short NITINOL line of pin sidewall in its proximal end at longitudinal direction.This line be designed to there is its not attached far-end and have from pin bending away from remember condition, to serve as the limiting member that penetrates about pin.This type of line will be tightly folding for pin, to reduce the diameter of distal section of INAS,

The use of two turn of bilges in pin, this turn of bilge forms and penetrates limiting member, and this turn of bilge is also in circumferentially, to do not increase the diameter of the distal section of INAS, and

Preferred embodiment comprises the use of bandy guiding tube, and pin slides through described guiding tube in a longitudinal direction.In this design, be incorporated in the near-end of INAS about the restriction penetrating, and do not require the diameter volume in INAS distal section.This last embodiment has the attendant advantages that allows to adjust penetration depth.Adjustment can comprise the labelling that allows the accurate degree of depth to adjust.

Can be that doctor controls or in device production process, be only come-at-able by the penetration depth adjustment of the mechanism in INAS near-end.In the first situation, the use of intravascular ultrasound or other imaging techniques can be used for the renal artery thickness of qualification at the desired area place for PVRD.Clinician is subsequently by the corresponding adjustment degree of depth.Also imagining INAS, can to use the degree of depth to be adjusted in factory preset, and described degree of depth adjustment will cannot approach for clinician, and if need multiple degree of depth, will provide different product coding.For example, three degree of depth can be obtainable, for example 2mm, 2.5mm and 3mm.Other advantages of factory's adjustable depth are to simplify to proofread and correct and mass formation, because may need the final factory of the pin degree of depth to adjust about the variation of the INAS of each production, make to provide the accurate degree of depth penetrating.In test and ratification process, using one or more preset degree of depth, to be limited in the latent fault arranging in the wrong degree of depth, is also advantage for factory's filing.Finally, imagination all can be incorporated in INAS with the available adjustment in outside with sounding mark about the internal adjustment of plant produced and correction.

Have the syringe of distal needle and be communicated with the injecting cavity fluid in catheter main body, described injecting cavity is communicated with the injection port fluid of the proximal end at INAS.This type of injection port generally will comprise AN connector, for example, for being connected to Rule adapter that melts fluid source.

This injecting systems also expects that the minimum gage needle of use (being less than 25 specifications) is to penetrate arterial wall, even if make plane or the volume of target tissue, it can be also safe that pin penetrates, described plane or volume be at aorta, pulmonary vein or arteriorenal theca externa place, or in aorta, pulmonary vein or arteriorenal theca externa depths (exceeding).Also expect that distal needle can be cutting needle or coring needle, and for cutting needle, injection outlet port can be at cutting needle point nearside, cuts to the little injection hole (hole) in sidewall or the distal needle of syringe.

Can expand syringe and can be the expansion certainly being formed by for example NITINOL of elastomeric material, memory metal, or they can be made up of metal or plastics, and can expand by other mechanical means.For example, the shank expanded with distally entry needle can be fixed to the outside that can expand air bag, and the described diameter of expanding air bag can be by the pressure control for aerating gasbag.According to pending blood vessel diameter, should have at least 2 syringes, and 3-8 pipe can be more suitably.For example, in 5mm diameter renal artery, may only need 3 or 4 pins, and in 8mm diameter kidney, may need 6 pins.

Whole INAS is designed to comprise fixing distally wire, or be advanced on wire in following configuration: wherein configuration on the line of the whole length of guidewire lumen operation INAS, or wherein wire at least leaves catheter main body in 10cm place in the distally of INAS near-end, and at the outside quick exchange configuration moving of the catheter shaft for its proximal section.The form of static line is preferred, because it will have minimum distally diameter.

INAS also will comprise tubular thin-walled sheath, and it retrains the syringe of expansion certainly with distal needle and/or guiding tube before expansion, and for taking out in body.This sheath also allows the far-end of INAS to be inserted in the near-end of guide catheter or guiding sheath.This sheath also acts on when INAS is when taking out in patient body, protects one or more operators in the time of EO, not to be subject to possible acupuncture and the exposure to blood-borne pathogens.

Also imagining entry needle, guiding tube and syringe can be formed by for example tantalum of radiopaque material or tungsten, or by the coating of for example gold of radiopaque material or platinum or by for example gold of radiopaque material or platinum labelling, to make their use fluoroscopy clearly visible.

Also imagine the near-end of one or more the be electrically connected to INAS in entry needle, to also serve as the one or more diagnostic electrodes for assessment of the electrical activity in vascular wall area.

Also imagination can be by 2 or more power supply or the RF source of being attached to can expanding in shank, so that the electric current around target vessel circumference or RF energy are delivered to a mouthful wall, to carry out tissue and/or nerve melts.

Also imagining this device can utilize one or exceed that a kind of nerve melts material simultaneously or with injection sequence injection, so that the permanent sympathetic nerve of optimization in renal artery section destroys (neurotmesis).The neurotoxin agent of available expection includes but not limited to ethanol, phenol, glycerol, for example, with the local anesthetic (lignocaine, or other reagent such as bupivacaine, cocaine, benzocaine etc.) of relative high concentration, there is neurovirulent anti-arrhythmic, botulinum toxin, digoxin or other cardiac glycosidees, guanethidine, add hot fluid comprise the nerve that adds hot salt brine, hypertonic saline, hypotonic fluid, KCl or heating melt material for example listed above those.

Also to melt material can be high seepage flow style as hypertonic saline (extra salt) or such as distilled water of hypotonic fluid to imagination.These also will cause neural permanent lesion, and can be equally good or even better with alcohol or specific neurotoxin.These also can hot or cold or room temperature injection.Have be less than the distilled water of 1ml volume injected, hypotonic saline or hypertonic saline use eliminate INAS use in a step, because these fluids of small size should be harmless to kidney, and therefore no longer need completely to rinse and melt the needs of fluid from INAS with normal saline, enter in renal artery in conduit extraction to prevent from melting any in fluid.If, only there is fluid injecting step of each tremulous pulse in the fluid that melts that this means to use more toxicity, instead of two steps.

The present invention also imagines the use of for example lignocaine of anesthetis, if first injection or melting in solution injection or inject together with melting solution, described anesthetis can reduce or eliminate any pain relevant to denervation operation.

Also imagination can be utilized imaging technique for example multi-slice Spiral CT, MRI, intravascular ultrasound or optical coherence tomography, for example, to obtain the thickness of target vessel wall (renal artery) and the definite measurement of anatomical structure, made before advancing entry needle or syringe, can understand and be provided for to inject the definite and correct penetration depth that melts reagent.It can be useful especially before use INAS, using IVUS, so that targeting expection is used for injecting cutting-in degree really.This definite degree of depth can be used the capable of regulating penetration depth targeting of feature in our one or more preferred embodiments subsequently.The selection of penetration depth can be used proximal section/handle, or has encoded by the proper product that selection is used for other designs, and described other designs can have two to five forms separately with different penetration depths restrictions.

For the use in the hypertension melting via kidney sympathetic nerve or CHF treatment, the at present preferred guiding tube embodiment of INAS of the present invention will use with following step:

1. take tranquilizer to patient, for example general (Versed) analgesic and narcosis analgesic to be similar to the mode that alcohol interventricular septum melts.

2. use standard tremulous pulse to approach method, make the first renal artery and engage through the guide catheter of femoral artery or radial artery placement.

3. comprise after injecting cavity in all chambeies with normal saline washing INAS, the INAS far-end with fixing distally wire is advanced in guide catheter.Device is advanced through guide catheter, until the far-end of guiding tube exceeds the desired location place of guide catheter far-end in renal artery.

4. retract sheath and allow can expand guiding tube and open, until the distal needle of guiding tube is outwards pressed renal artery inwall.This can be confirmed by the visual of radiopaque tip of guiding tube.

5. next, radiopaque syringe/coaxial needle is advanced through guiding tube, penetrate by internal elastic membrane (IEL) and enter in arteriorenal blood vessel wall with the preset distance place exceeding IEL (be generally 0.5-4mm, but preferred about 2-3mm).Ideally, can be advanced in the renal artery～2-3mm degree of depth of minimum specification entry needle, with membrane plane place outside or outside membrane plane depths send one or more nerves and melt reagent, to make inner membrance and middle film injury of renal artery drop to minimum.Correct depth can use CT scan, MRI, OCT or intravascular ultrasound measure before INAS treatment, and to measure renal artery wall thickness, the correct initial depth that makes to penetrate for syringe is arranged on and advances pin is known before.

6. the nerve of injection suitable volumes melts fluid, for example ethanol (ethyl alcohol), distilled water, hypertonic saline, hypotonic saline, phenol, glycerol, lignocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin or other suitable neurotoxicity fluids.This can comprise that two or more nerves melt fluid or local anesthetic together or in turn (first local anesthetic reduces discomfort, subsequently for melting sending of reagent) and/or high temperature fluid (or steam) or extremely cold (cryoablation) fluid be combined into blood vessel wall and/or just in time in the volume of blood vessel outside.General injection will be 0.1-5ml.This should produce multiple zones of ablation band (for one, each syringe/pin), and described district band will intersect to form and melt ring around target vessel circumference.Contrast agent can the test injection process before nerve melts reagent in or in treatment injection process, add in injection, to allow the x ray of zone of ablation band visual.

7. the normal saline solution that is enough to rinse completely the injecting cavity (dead space) that melts reagent and leave INAS is expelled in INAS.This prevents from melting any in reagent and is withdrawn in INAS process and drops in renal artery at pin.This type of accidental discharge entering in renal artery can cause the infringement to kidney.If distilled water, hypotonic or hypertonic saline are as melting fluid, this step can be avoided.

8. INAS syringe/pin is retracted to guiding tube inside.Subsequently, by sheath is advanced on guiding tube, guiding tube is shunk again and reenter sheath.This is turning back guiding tube completely under the sheath of prong.Whole INAS can be withdrawn in guide catheter subsequently.

9. in some cases, INAS can be rotated to 20-90 degree, or INAS is relocated to the first distally, injection site or nearside 0.2-5cm, and duplicate injection when needed subsequently, to prepare the second ring or even more definite rings that melts.

10. can repeat and the method identical according to previous steps, to melt the tissue in contralateral kidney tremulous pulse.

11. take out INAS completely from guide catheter.

12. take out all residue apparatuses in body.

13. can use similarity method for INAS, enter in left atrium with treatment AF, via the ablation of tissue in one or more pulmonary venous blood vessel wall via approaching across interventricular septum.When instruction, advance suitable diagnosis electrophysiology duct confirming to melt (in the situation that of atrial fibrillation), be successful.

Also imagine available pin syringe is fixed on the outer surface of the air bag expanded on INAS, to 2 or more pins are delivered in the blood vessel wall of target vessel, melt fluid to inject.

Although main embodiment of the present invention is utilized three or more pin injection sites, with by alcohol or one or more other neurotoxicity fluid circumference are administered to renal artery wall or melt for sympathetic nerve renal artery wall depths, but also imagine this concept other modify and also can be used for realizing identical result.In one case, imagination is by by the space of melting between fluid injecting to two aerating gasbag, and fluid based on circumference (ethanol or other melt fluid, melt the combination of fluid or add hot fluid) can circumference mode be applied to arteriorenal " ring section ".Therefore, after inflation nearside occlusion balloons and distally occlusion balloons, in the space of melting between fluid injecting to two aerating gasbag, and allow to stop short time period, allow fluid for example ethanol penetrate by arterial wall and arrive theca externa, therefore destroy and melt the sympathetic nerve moving in this space.After retention, air bag deflation can and be given with normal saline washing in space.

Similarly, near single air bag air bag centre with minor diameter can work in the same manner, and the combination or the heating fluid injecting that melt fluid by ethanol or other or melt fluid do not contact in " saddle sample " space of arterial wall in air bag middle body.

Also imagine circumference polymer, hydrogel or other belt carriers on the middle body that another embodiment can be included in aerating gasbag, wherein carrier contains one or more neurotoxin agent, such as alcohol, phenol, glycerol, lignocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin etc.Air bag can be relatively low pressure inflatable, with the intimal surface of relative kidney arterial wall, and the inflation time of staying to be to allow neurotoxin agent circumference to penetrate in arteriorenal " ring section ", and near the sympathetic fiber that allows membrane plane outside or move in membrane plane outside melts.

Also imagine INAS conduit and can be connected to and add hot fluid or vapour source, to send high temperature fluid to melt or to damage target tissue or nerve.Adding hot fluid can be normal saline, high seepage flow body, hypotonic fluid alcohol, phenol, lignocaine or some other combination of fluids.Also can carry out saline, hypertonic saline, hypotonic saline, ethanol or distilled water or other fluids vapor injection via pin, to realize in pin injection site place and the target tissue around pin injection site or neural heating ablation.

Also imagine INAS and can utilize the very small diameter pin syringe (for example 25-35 specification) at its far-end with prong, make to use one or more combinations that limiting member or guiding tube and syringe advance through the adjustable depth of guiding tube that penetrate, to penetration depth is set, pin is advanced to or even passes the outer membrane plane of renal artery or aorta wall, and allow to comprise orthosympathetic theca externa with neurotoxicity fluid " immersion ", inner membrance and middle film blood vessel parietal layer are caused to MIN damage simultaneously.These ultra fine needle thoroughly wall through arterial wall, still produce this type of very little hole in arterial wall, make blood leakage from chamber to blood vessel outside and rete damage will be MIN, and be therefore safe.Therefore, the present invention can have and enters in renal artery wall, enters in renal artery adventitia or the injection of arteriorenal theca externa (adventitia week) depths, make entry needle or occur straight through penetrating of arterial wall via one from the outflow of syringe, to allow to melt, fluid flows around tremulous pulse and melt material " immersion " with one or more nerves tremulous pulse is outside.

Another embodiment can be included in two or more holes on the outer surface of middle body of aerating gasbag, or little metal (extremely short) pin is as outthrust, described hole or outthrust are communicated with injecting cavity fluid, to allow to be expelled in arteriorenal wall and to allow the circumference of one or more neurotoxin agent to send.Consider these instruction and embodiment descriptions, can imagine other similar techniques, allowing can to expand at the air bag melting for renal artery sympathetic nerve, these notional other variations of circumferential ablation system.

Described in method above, the instrument that the preferred embodiments of the present invention penetrate restriction blood vessel wall is placed in the proximal end of INAS.In this embodiment, there are at least three guiding tubes can expanding distal part along the distal part operation of INAS length.The guiding tube controlling organization with optional irrigation ports is attached to the near-end of INAS, and controls the lengthwise movement of guiding tube.

Comprise a syringe for each guiding tube, wherein syringe has at needle point place or just in time has at needle point nearside sharp-pointed (coring needle or cutting needle) far-end of one or more injection outlet ports.Syringe is coaxially positioned at guiding tube inside.Sharp-pointed entry needle at first just in time " is placed in " nearside of guiding tube far-end at the far-end of syringe far-end.Near-end syringe controlling organization is attached to the near-end of syringe, or in a preferred embodiment, is attached to the near-end of single syringe, and described single syringe is connected to multiple syringes by connecting manifold.Syringe controlling organization will advance entry needle to leave the extremely required penetration depth of far-end of guiding tube in the time advancing.Penetrating and how being subject to an example of INAS proximal section restriction is to have the syringe controlling organization separating at its far-end and the near-end of guiding tube controlling organization, forms pin and advances gap.Syringe controlling organization can have the advance instrument of clearance distance of the pin of adjustment.Alternatively, adjustment can be on guiding tube controlling organization or on the separating mechanism between syringe handle and guiding tube handle.For injecting, to melt the accessory of fluid attached near the near-end of INAS, and be communicated with the injecting cavity fluid of syringe.

Sheath is positioned at the guiding tube outside that retrains it in its initial configuration.The proximal attachment of sheath is to sheath handle, and it can lock downwards to prevent the lengthwise movement with respect to guiding tube, or release is to allow sheath to move at nearside or distal direction, to open and to close INAS.

The process that uses INAS proximal section is the each chamber in INAS with normal saline flushing.Subsequently the far-end of INAS is advanced through guide catheter intravasation for example in renal artery.Retract subsequently sheath joystick, guiding tube handle is held in place.This by allow guiding tube distal part for blood vessel for example renal artery wall to external expansion.Optionally, after sheath retracts, guiding tube can use guiding tube handle to promote forward gently subsequently, to guarantee that they are for blood vessel wall firm engagement.Syringe handle so advances subsequently, so that the syringe far-end that promotes to have a sharp-pointed entry needle leaves the far-end of guiding tube, the inside of described guiding tube contact blood vessel wall.Pin will penetrate in the middle film of blood vessel wall.According to advancing gap, can limit penetrating in pin intravasation wall.According to number and the position of injection outlet port, this can allow to be expelled to middle film, adventitia, adventitia outside (adventitia week) or these any combination by the injection outlet port selectivity of pin.Suitably be placed in blood vessel wall or through after blood vessel wall, be attached to the accessory in syringe handle by melting for example ethanol of fluid source at pin, and by fluid injecting by the chamber of syringe inside and export port by injection and leave and enter in tissue.

After injection completes, syringe handle is retracted, so that pin is retracted in the distal part of guiding tube.Subsequently sheath joystick is advanced, with folding guide pipe and close INAS.Subsequently sheath joystick is locked downwards, to prevent that the involuntary of INAS from opening.Subsequently INAS is withdrawn on guide catheter, and can repeats same operation for other renal artery.

In a preferred embodiment, the proximal section of INAS has a handle, and described handle comprises sheath controlling organization, guiding tube controlling organization and syringe controlling organization.This preferred embodiment has two mobile sections.Be attached to first of sheath controlling organization and move section and move sheath with respect to guiding tube, second moves section moves syringe with respect to guiding tube.These move section and also have ideally separately locking mechanism, mobile to prevent.In addition, will there is interlocking in imagination between two mobile sections, unless made guiding tube expansion and to external expansion, otherwise can not advance pin, and second interlock, unless pin nearside be retracted in guiding tube, otherwise prevent that sheath from closing.Latching/delatching mechanism can be depressed with release and discharge the button with locking, or reverses to lock and reverse the rotating ring with release with another direction with a direction.

Preferred embodiment will use following press button mechanism.Press the first button moving on section, described first moves section is attached to sheath controlling organization.This is by its movement with respect to guiding tube controlling organization of release.This first moves section nearside pull-up, makes the remainder of handle keep fixing simultaneously.This will pull sheath in the proximal direction with respect to guiding tube, allow guiding tube for renal artery inside to external expansion.Discharge this button sheath controlling organization is locked onto to the guiding tube controlling organization in sheath open position, discharge the interlocking that prevents that syringe controlling organization from advancing.

Press the second button moving on section, described second moves section is attached to syringe controlling organization, and release syringe controlling organization is with respect to the movement of guiding tube controlling organization.The syringe that advances the promotion of syringe controlling organization to have prong leaves, through in the far-end and intravasation wall of guiding tube.Release-push, locks onto guiding tube controlling organization by syringe controlling organization.In this configuration, in the time that pin launches, interlocking will prevent that first moves section and can advance sheath with respect to guiding tube.Melt material injection and with after normal saline washing INAS, reversing two steps.Be depressed now at the second button moving on section, and syringe and pin nearside are retracted in guiding tube.Release-push locking phase is for the syringe controlling organization of guiding tube controlling organization, and release prevents the interlocking that sheath is closed.

Can be depressed now at the first button moving on section, and sheath controlling organization is with respect to the propelling of guiding tube controlling organization distally, close INAS, and guiding tube is retracted under sheath now.

In another embodiment, second moves section is attached to guiding tube controlling organization, and syringe controlling organization is the 3rd to move section.Herein, second moves only release syringe controlling organization and guiding tube controlling organization of section, and syringe controlling organization is the mechanism that distally promotes to advance the syringe with sharp-pointed entry needle.

Although described button above, also imagined rotation with locking and separated the ring relatively moving of lock control mechanism.

The radiopacity of the specific part of conduit is crucial for the use of INAS.Ideally, be radiopaque at the fixing cord of INAS far-end.This will be also at following one or more radiopaque labellings: at sheath far-end, in the portions of proximal of the distal tip (occluder) of the INAS closing for sheath far-end, in the end of each guiding tube and the far-end of each syringe/pin or whole length.Can use the becket of tungsten, tantalum, gold or platinum, maybe can use by for example barium of dense material or tungsten and fill the radiopaque plastics that form.Entry needle can have by the pin of radiopaque metal plating or needle point, or if coring needle can use the sharp-pointed radiopaque plug in needle distal.Also imagine radiopaque line and can be placed on entry needle inside, to strengthen radiopacity.For example, have that more the platinum of minor diameter or gold thread can be fixed on the inside in each pin chamber than pin chamber.

Therefore in expansion INAS, the labelling in sheath and distal tip will separately show the contraction of sheath.The labelling end of guiding tube will clearly show them separately and contact internal blood vessel subsequently.In the time advancing, syringe/pin is extending beyond guiding tube far-end and visible during clearly in lumen of vessels depths, and this uses guide catheter to follow contrast-medium injection visible.Imagination can show the following labelling from central authorities to outside clearly at the fluoroscopy that INAS distal part 90 degree places are carried out:

The radiopaque ring of labelling sheath far-end

Outside at ring, at the radiopaque labelling of guiding tube end

In radiopaque labelling outside, exceed the distal tip of each guiding tube, stretch out through the distal part of the entry needle of blood vessel wall.

Although imagination can exist the number of from one to 8 syringe/pin 8 guiding tube inside, may 2,3 or 4 pipes be best for circumference ablation of tissue.

Another key character of INAS of the present invention is the design of internal volume that reduces INAS " dead space ", leaves conduit and enters the salt water yield required in required tissue volume and drop to minimum flushing is melted to fluid.Expection need to be less than 1ml melt fluid for example ethanol with carry out PVRD.Dead space should be less than 1ml, is also less than better 0.5ml and is less than ideally 0.2ml.Have some design feature, imagination dead space can be reduced to less than 0.1ml.This category feature comprises that use minor diameter <0.5mm ID hypotube is for inner tube, described inner tube is for the fluid injecting of INAS, comprise that volume occupies structure example as being placed in the line in the total length of hypotube/inner tube, to reduce hypotube and the therefore volume of INAS dead space, and/or by having little <0.5mm internal diameter and short <2cm length, design has nearside injection port and or the injection manifold of small size in the proximal end of INAS.A kind of technology that is envisioned for the dead space that reduces INAS injecting cavity inside is the line having in one or more inside in chamber, to occupy volume.

Although guiding tube embodiment, by works fine, drops to minimum minor diameter pin to allow to use by the potentiality of losing blood, also imagine other designs, comprising:

Have the minor diameter syringe/pin that can remove stylet, described stylet will provide radiopacity and/or the structural strength of enhancing, to allow forming tube/pin correct outwardly-bent and penetrate blood vessel wall.

Insert the minor diameter pin in the preform plastics of larger diameter or the far-end of metal injection pipe

Therefore, the object of INAS of the present invention is the conduit with dermal delivery, the conduit of described dermal delivery can be used for treating atrial fibrillation, follows to melt fluid one or many and be expelled near pulmonary venous blood vessel wall mouth, or in the one or more left atrial tissue in pulmonary vein.

Another object of INAS of the present invention is the conduit with dermal delivery, the conduit of described dermal delivery can be used for treating hypertension, follow and melt fluid one or many and be expelled in arteriorenal blood vessel wall or arteriorenal blood vessel wall depths, or in the aorta wall of renal artery ostium.

Another object of INAS of the present invention is to be conducive to by melting fluid injecting in renal artery skin or exceeding renal artery skin, to reduce or to prevent internal layer to comprise the damage of film in renal artery.

Another object of INAS of the present invention is to have the design that is less than 0.2ml and is less than ideally the limited dead space of 0.1ml.

Another object of the present invention is the two injecting step methods that have for kidney denervation, wherein conduit is full of normal saline before in insertosome, subsequently after pin launches, complete first injection of melting fluid (for example ethanol), subsequently for using normal saline or to all second steps that melt fluid and leave conduit of the nontoxic similar fluid flushing of kidney.Close INAS and identical two injecting step for other renal artery.

Another object of the present invention is to utilize distilled water, height to ooze or hypotonic fluid melts fluid as what select.This can reduce to the injection of melting fluid each renal artery shot (step) and shortening program.

The another one object of INAS of the present invention is the conduit with dermal delivery, the conduit of described dermal delivery comprises that multiple circumference can expand syringe, each pipe has the pin at its far-end with injection outlet, allows to melt fluid and is delivered in target vessel wall or exceeds in the space of blood vessel wall.

Another object of the present invention is to have flexibility to penetrate limiting member or instrument, and described member or instrument are just in time attached to the nearside of every entry needle far-end, or the guiding tube at relatively blunt tip, to limit in pin intravasation wall or just in time through the degree of depth of blood vessel wall.

Another object of the present invention is to have sheath, and described sheath is combined with distal tip provides the opening and closing of INAS position.Closed position has sheath and the distal tip of contact like this, to encapsulate prong completely, and open position allows pin to external expansion, for melting fluid injecting in blood vessel wall or blood vessel wall depths.

Another object of the present invention is to use heating or the cooling fluid that melts for example to use heating or cooling normal saline as ablation of tissue source, or strengthens the effect that has melted for example ethanol of fluid.

The another one object of INAS of the present invention is to have one or more in entry needle to serve as the diagnostic electrode for measuring the electrical activity in target vessel wall.

Another object of the present invention is the syringe that uses many coaxial guiding, described syringe moves slidably corresponding expansion in guiding tube, enter and/or through safe, the control of target vessel wall and the process of adjustable depth with the syringe that allows to there is prong at its far-end, to allow the neural control chemical ablation in adventitia or the adventitia perisphere of tremulous pulse, make the inner membrance of described tremulous pulse and middle membrane damage drop to minimum simultaneously.

Another object of the present invention is before fluid injecting or in injection process, to provide narcotic injection melting, to prevent or any pain that minimizing is relevant to denervation operation.

Another object of the present invention is to comprise one or more in following radiopaque labelling, to help to locate, open, close and use INAS.These comprise following:

The radiopaque ring of labelling sheath far-end

At the radiopaque labelling of guiding tube end, there are metal tape or the plastics of for example barium of radiopaque filler or tungsten

Radiopaque labelling in the distal part of entry needle

At radiopaque line of the intracavity portion of syringe and/or entry needle

The skin of radiopaque labelling or fixing cord

Read detailed description of the present invention comprise after accompanying drawing, of the present invention these and other objects and advantages will become apparent for those of ordinary skill in the art.

Brief description of the drawings

Fig. 1 is the longitudinal cross-section figure of the distal part of nervus vasculairs ablation system of the present invention (INAS), and described INAS has fixing cord at its far-end.

Fig. 2 is delivered in human body or cover entry needle from human body taking-up process time when INAS is configured for, the schematic diagram of the distal part of INAS in its closed position.

Fig. 3 is configured for when melting solution and be delivered in target vessel wall as INAS, the schematic diagram of the distal part of INAS in its open position.

Fig. 4 is the longitudinal cross-section figure of the near-end of the static line embodiment of the INAS of Fig. 1 to 3.

Fig. 5 A is when first INAS being advanced when leaving guide catheter and entering in renal artery, the schematic diagram of the distal part of the closed INAS of Fig. 2.

Fig. 5 B is in the time that sheath is pulled to allow can extension tube to open for the renal artery wall in mouth distally, the schematic diagram of the distal part of closed INAS.

Fig. 5 C is the schematic diagram of the distal part of the INAS opening completely of Fig. 3, and wherein pin embeds in renal artery wall completely, is infused in blood vessel wall to allow melting material.

Fig. 5 D is that the distal part as INAS is pulled back in sheath to close INAS, or in the follow-up use of other renal artery or when taking out in body, the schematic diagram of the distal part of closed INAS.

Fig. 5 E is retracted in sheath and is closed by the distal part of INAS as INAS, or in the follow-up use of other renal artery or when taking out in body, the schematic diagram of the distal part of the closed INAS of Fig. 2.

Fig. 6 is the longitudinal cross-section figure of the embodiment of INAS, and described INAS sends on the wire separating.

Fig. 7 is the longitudinal cross-section figure of the near-end of embodiment on the line of INAS of Fig. 6.

Fig. 8 can will add heating ablation solution and be delivered to the longitudinal cross-section figure of the syringe in the INAS of Fig. 1-4.

Fig. 9 is the longitudinal cross-section figure of the proximal section of entry needle, shows that longitudinal sealing wire penetrates limiting member.

Figure 10 is the longitudinal cross-section figure of the proximal section of an alternative embodiment of the invention, and described embodiment will melt fluid circumference and be delivered to the inside of target vessel.

Figure 11 is the longitudinal cross-section of another embodiment of INAS of the present invention in its closed position, and described INAS has four syringes that can slide in four guiding tubes.Syringe has prong, and described prong has the injection outlet port at the far-end of each syringe.

Figure 12 is the amplification of the region S12 of Figure 11, shows the distal part of syringe and guiding tube.

Figure 13 is the circle type cross section at the S13-S13 place of the INAS of Figure 11.

Figure 14 is the longitudinal cross-section of the expansion distal part of INAS.

Figure 15 is the amplification of the region S15 of Figure 14.

Figure 16 is the longitudinal cross-section of the INAS near-end of Figure 11-15.

Figure 17 is the amplification of the region S17 of Figure 16.

Figure 18 is the amplification of the region S18 of Figure 16.

Figure 19 is the longitudinal cross-section of the whole alternate embodiments of INAS except distal part, and described INAS uses multiple guiding tubes.

Figure 20 is the longitudinal cross-section of central transition portion, and described central transition portion connects the INAS portions of proximal of Figure 19 and the INAS distal part of Figure 11-14.

Figure 21 is the circle type cross section at the S21-S21 place of the INAS of Figure 20 central authorities transition portion.

Figure 22 is the circle type cross section at the S22-S22 place of the INAS of Figure 20 central authorities transition portion.

Figure 23 is the circle type cross section at the S23-S23 place of the INAS of Figure 20 central authorities transition portion.

Figure 24 is the longitudinal cross-section of the near-end of the alternate embodiments of INAS, and described INAS has coring needle, and described coring needle has radiopaque line at its intracavity, so that the visual of pin to be upon deployment provided.

Figure 25 A is longitudinal cross-section, shows the guiding tube of INAS of Figure 24 and the amplification of the distal part of coring needle.

Figure 25 B is the alternate embodiments of the distal section S25 of the INAS of Figure 24, and described INAS has the structure about syringe identical with Figure 25 A, but has metal tape as the radiopaque labelling for guiding tube.

Figure 26 is the schematic diagram of the embodiment of INAS portions of proximal, and described INAS portions of proximal has the locking mechanism activating by can pressing button.

Figure 27 is the schematic diagram of the pin section of another embodiment of INAS of the present invention, and described INAS has the heart yearn and the non-circular cross sections guiding tube that are formed by three twisted wires.

Figure 28 is the middle body in the cross section at the S28-S28 place of the INAS of Figure 27.

Figure 29 is the schematic diagram of the distal part of the another one embodiment of INAS, and described INAS has stranded core and circular cross section guiding tube.

Figure 30 is the schematic diagram of the interior section of INAS, and described INAS clearly shows the near-end of radiopaque line, and the length of described radiopaque line operation syringe, to provide radiopacity.

Figure 31 is the cross section at the S31-S31 place of Figure 30.

Figure 32 A is the schematic diagram of the embodiment of INAS distal part, and described INAS distal part has non-circular guiding tube.

Figure 32 B is the end on the schematic diagram of the guiding tube of displayed map 30A.

Figure 33 is the schematic diagram of the alternate embodiments of INAS handle, and described INAS handle uses rotation motion between mobile section with the locking and unlocking of member.

Figure 34 is the guiding tube of another embodiment and the schematic diagram of syringe of INAS of the present invention, and described INAS has three guiding tubes that separate with main traverse main body.

Figure 35 is the schematic diagram that the present invention has the another one embodiment of the INAS of syringe, and described syringe has distal needle, and described distal needle has injection outlet port.

Figure 36 A is the longitudinal cross-section view of another embodiment of the distal part of entry needle.

Figure 36 B is the longitudinal cross-section view of the another one embodiment of the distal part of plastic injection pipe, and described plastic injection pipe has the entry needle inserting in its far-end.

Figure 36 C is the longitudinal cross-section view of the another one embodiment of the distal part of metal injection pipe, and described metal injection pipe has the entry needle inserting in its far-end.

Detailed description of the invention

Fig. 1 is the longitudinal cross-section figure of the distal part of nervus vasculairs ablation system of the present invention (INAS) 10, and the distal part of described INAS10 has fixing cord 25, and described fixing cord 25 has the tip 28 at its far-end.Fig. 1 shows the INAS10 in its fully open position, and described INAS10 has from expansion syringe 15, and described have sharp-pointed far-end from expansion syringe 15, to form the entry needle 19 that is opened to its maximum gauge.The soft cotton rope 13 with binding agent 14 serves as and penetrates limiting member, exceedes in ultimate range L intravasation wall to prevent that the distal tip of pin 19 from penetrating, and rope 13 is attached to syringe 15 by described binding agent 14.Syringe can be made up of any elastomeric material, and wherein preferred material is NITINOL.If pipe to reach identical object, can be placed in syringe inside by the spring separating or aerating gasbag from expansion.Air bag can be pushed to pin in blood vessel wall with great power in increasing system diameter.

The sheath 12 with radiopaque labelling 27 is shown in Fig. 1, and in described position, it has retracted to allow the expansion completely of syringe 15.In this embodiment of INAS10, there are 4 syringes 15, lack to 2 and reach 12 syringes 15 although imagined.Distance L can be between 0.2-2mm, and wherein the best is about 1mm.

The distal section 20 of INAS10 comprises distally line 25, taper flexible tip 26, radiopaque labelling 24 and sheath junction section 22, described sheath junction section 22 guarantees that at INAS10, for melting after the tissue of human vas, the distal part of INAS10 will suitably be withdrawn in sheath 12.INAS10 closes completely in the time that two radiopaque labellings 27 and 24 abut one another.This provides vision instruction in fluoroscopy process.

The near-end of syringe 15 is kept by manifold 17, and described manifold 17 is attached to the far-end inside of outer tube 16 and heart yearn 11.The proximal attachment of outer tube 16 is to hypotube 18, and described hypotube 18 arrives the near-end of INAS10 continuously.Hypotube 18 is generally made up as 316 rustless steels of metal, and outer tube 16 is made up of plastics or metal reinforced plastics, make its enough flexible to allow the turn of bilge of INAS in typical guide catheter easily to advance and contraction around, described guide catheter is for example for the guide catheter of arteriorenal angioplasty or support.The general long 5-30cm of outer tube 16, can design such INAS10 although also imagined, plastics or metal reinforced plastics outer tube 16 that it does not contain hypotube 18 and only runs to near-end.

Heart yearn 11 is attached to the inside of hypotube 18 at junction point 23 places.This is attached can be for example by adhesion mode, welding or brazing.Spot welding is method for optimizing.By this way, the heart yearn 11 of support static line 25 can easily depart from INAS10.Be connected to the chamber of outer tube 16 at the injecting cavity 21 of hypotube 18 inside, the chamber of described outer tube 16 with can extension tube 15 in each injection tube chamber 29 fluids be communicated with, allow to melt material or solution from the near-end of INAS10 flow through hypotube 18, by outer tube 16, by expanding syringe 16 and leave in sharp-pointed entry needle 19 intravasation walls.

Fig. 2 is delivered in human body or cover entry needle 19 from human body taking-up process time when INAS10' is configured for, the schematic diagram of the distal part of INAS10' in its closed position.INAS10' comprises static line 25, heart yearn 11, outer tube 16 and the sheath 12 with most advanced and sophisticated 28.In this configuration, two radiopaque labellings 27 and 24 are located adjacent one another, and wherein sheath 12 is advanced to its complete distal position.In this design, be significant: in closed position, prong 19 is encapsulated completely by sheath 12, and described sheath 12 is closed in the portions of proximal of cone point 26.

Fig. 3 is the distal part of neural ablation system (INAS) 10 in the blood vessel of the present invention schematic diagram in its fully open position, and the distal part of described INAS10 has fixing cord 25, and described fixing cord 25 has most advanced and sophisticated 28 in its distal side.Fig. 3 shows the INAS10 in its fully open position, and described INAS10 has from expansion syringe 15, and described have sharp-pointed far-end from expansion syringe 15, to form the entry needle 19 that is opened to its maximum gauge.The soft cotton rope 13 with binding agent 14 serves as and penetrates limiting member, exceedes in the intravasation of ultimate range L shown in Fig. 1 and 3 wall to prevent that the distal tip of pin 19 from penetrating, and rope 13 is attached to syringe 15 by described binding agent 14.

The sheath 12 with radiopaque labelling 27 is shown in Fig. 3, and in described position, it has retracted to allow the expansion completely of syringe 15.In this embodiment of INAS, there are 4 syringes 15.The distal section 20 of INAS10 comprises fixing distally line 25, taper flexible tip 26, radiopaque labelling 24 and sheath junction section 22, described sheath junction section 22 guarantees that at INAS10, for melting after the tissue of human vas, distal part will suitably be withdrawn in sheath 12.What also show at Fig. 3 is the outer tube 16 with injecting cavity 21 and heart yearn 11.

Fig. 4 is the longitudinal cross-section figure of the near-end of the static line embodiment of the INAS10 of Fig. 1 to 3.The hypotube with injecting cavity 21 18 also showing at Fig. 1 has Rule accessory 35, described Rule accessory 35 has the chamber 36 that is attached to its near-end, allow the solution that melts substance source to be injected the chamber 36 by Rule accessory 35, enter in the injecting cavity 21 of hypotube 18, and leave subsequently the entry needle 19 of Fig. 1 to 3.The proximal attachment of sheath 12 is to the far-end of Tu Yi-Bo Site accessory 30, and described Tu Yi-Bo Site accessory 30 has handle 36, interior hub 33, packing ring 39 and O shape ring 43.When handle 36 obtains on interior hub 33 when fastening by it is screwed into downwards, O shape ring will be for hypotube 18 compression seal Tu Yi-Bo Site accessories 30.The side pipe 31 with Rule accessory 32 that contains chamber 34 was designed to allow before INAS10 is inserted in human body, the chamber 38 with normal saline washing between sheath 12 and hypotube 18 inside.Before in insertosome, Tu Yi-Bo Site accessory 30 is fastened in hypotube 18, wherein sheath 12 is closed as shown in Figure 2 in its farthest side position and INAS10'.In the time that the far-end of INAS10' is suitably arranged in one of renal artery, Tu Yi-Bo Site accessory is unclamped, and handle 36 is pulled in proximal direction, and Rule accessory 35 is held in place.This by open INAS10 and allow the syringe 15 of Fig. 1 in blood vessel to external expansion.

Fig. 5 A is when first INAS10' being advanced when leaving guide catheter 80 and entering just in time in the renal artery in aortic orifice distally, the schematic diagram of the distal part of the closed INAS10' of Fig. 2.INAS10' is advanced until in the indicia band 24 in the distally of the far-end of guide catheter 80.The optimum distance in expection 5-15mm distally is by best effort, although enter the distance that penetrates in renal artery ostium according to arteriorenal geometry and guide catheter 80, shorter and longer distance is also possible.

Fig. 5 B is pulled when sheath 12, with allow can extension tube 15 for just in time in the time that the renal artery wall that enters endaortic mouthful of distally is opened, closed INAS10 " the schematic diagram of distal part.In this position, the angle A that the far-end of wishing entry needle engages blood vessel wall inside thereon should be less than 80 degree, and ideally between 40-60 degree.If this angle is too large, syringe can fasten backward, instead of prong is pushed in blood vessel wall.If this angle is too little, pin may inappropriately penetrate and may slide along the inner distally of blood vessel wall.Be pulled and it no longer retrained can expand after syringe 15 at sheath 12, subsequently by INAS10 " promote in distal direction, while allowing when entry needle 19 penetrates into renal artery wall in, syringe 15 continuation its to external expansion.When rope 13 engages renal artery walls, when the penetrating of restriction pin 19, penetrate and will stop.Alternatively, this " rope " is replaceable is nitinol wire structure, and its elasticity is attached to syringe 15, to provide (harder) metal to penetrate limiting member.

Fig. 5 C is the schematic diagram of the distal part of the INAS10 opening completely of Fig. 3, and wherein pin 19 embeds in arteriorenal wall completely, is infused in blood vessel wall to allow melting material.Although Fig. 5 C shows the rope 13 of expansion completely, they are generally slightly less than its maximum gauge in the time that they engage arteriorenal wall in diameter, to limit penetrating of pin 19.Preferably, selection should be than greatly at least 2-4mm of arteriorenal internal diameter for the maximum gauge of the INAS10 system of this operation.For example, if be 5mm at the renal artery diameter at required ablation site place, should select the INAS10 of the maximum gauge with 7-9mm in diameter.In the configuration of Fig. 5 C, will melt material injection and enter in arteriorenal wall by pin 19.Preferably melting material is ethyl alcohol (ethanol), and described ethyl alcohol is in history for ablation tissue, preferably the nervous tissue in cardiovascular system.Other reagent are also expected as possible injected material (injectates) as phenol, glycerol, one or more local anesthetics for example lignocaine, guanethidine or other cytotoxic agents and/or neurotoxin agent.

Fig. 5 D is when INAS10 " distal part be pulled back in sheath 12 to close INAS10 ", or in the follow-up use of other renal artery or when taking out in body, closed INAS10 " the schematic diagram of distal part.Shadow region shows the zone of ablation 100 that wherein organizing in renal artery wall melted.For example, if the penetration depth of pin is made as the larger degree of depth (2.5-3mm), zone of ablation band can be darker (being mainly adventitia), and inner membrance and middle rete to renal artery wall causes than damage less shown in Fig. 5 D.

Fig. 5 E is retracted in sheath 12 and is closed by the distal part of INAS as INAS10', or in the follow-up use of other renal artery or when taking out in body, the schematic diagram of the distal part of the closed INAS10' of Fig. 2.

For this embodiment of INAS10, will be following step for hypertensive method:

1. sterilized INAS10 is fetched into aseptic area from its packaging, the chamber 38 with normal saline washing between outer tube 12 and hypotube 18.

Advance sheath 12 until INAS10' in its closed position.

3. Tu Yi-Bo Site accessory 30 is locked onto downwards in the hypotube 18 of Fig. 4.

4. approach aorta via femoral artery, generally follow the insertion of guiding sheath.

5. use Fig. 5 A to the guide catheter 80 of 5E or there is the guide sheath of sharp-pointed far-end, engaging the first targeting renal artery by aorta.This can be confirmed by contrast-medium injection as required.

6. the far-end of INAS10 is placed in the near-end of guide catheter 80 with the closed position of its Fig. 2.General Tu Yi-Bo Site the accessory that has the far-end that is attached to guide catheter 80, loses blood to retrain.

7. Tu Yi-Bo Site accessory that the INAS10 of closure can promote by opening enters in guide catheter 80.

8. as shown in Figure 5A, advance INAS10 by guide catheter, until the distally of the guide catheter far-end of indicia band 24 in renal artery.

9. retract sheath 12 in proximal direction, make Rule accessory 35 of INAS10 near-end and hypotube 18 keep fixing simultaneously.As shown in Figure 5 B, this will allow syringe 15 to expand for arteriorenal wall.

10. Tu Yi-Bo Site accessory 30 is locked onto downwards in hypotube 18.

11. follow at Tu Yi-Bo Site accessory of the proximal end of guide catheter 80 and unclamp, and advance the sheath 12 and the hypotube 18 that lock together, in the time certainly expanding syringe 15 and continue to external expansion, promote that prong 19 enters or by arteriorenal wall.Engage arteriorenal wall when penetrating limiting member 13, thereby when restriction pin 19 penetrates desired depth, syringe 15 will stop penetrating.

Syringe or injecting systems are attached to Rule accessory 35 of Fig. 4 by 12., and described syringe or injecting systems provide the fluid that melts being expelled in arteriorenal wall.

13. by the ethanol of suitable volumes (ethyl alcohol) or other suitable cell toxicant fluids or neural melt the combination of fluid or the fluid of heating or steam (for example saline solution of 90-95 degree heating) from syringe or injecting systems injection by chamber 36 and leave pin 19 and enter in renal artery wall.General injection will be 0.3-5ml.Shown in zone of ablation as shown in Fig. 5 D and 5E, this should produce multiple crossing ablated volume (for one, every pin), and described ablated volume should be created in renal artery circumference ablation tissue anchor ring around.For example lignocaine of contrast agent and/or anesthetis can be before melting fluid or with melt fluid and inject simultaneously.Before syringe/pin shrinks, saline can be used for that nerve is melted to fluid flushing and leaves dead space.

14. unclamp Tu Yi-Bo Site accessory 30, and make Tu Yi-Bo Site accessory 30 and sheath 12 keep fixing simultaneously, pull the Rule 35 with hypotube 18 in proximal direction, until there is can extension tube 15 being fully retracted in the far-end of sheath 12 of pin 19, and indicia band 27 and 25 abuts one another.This is shown in Fig. 5 D and 5E.

15. in some cases, INAS10 can be advanced in renal artery again, and it is rotated between 20-90 degree, and duplicate injection subsequently, to make melting of even more definite volumes.Be less than 4 syringes if INAS10 has, this will be favourable, and in this article without showing 4 syringes.

16. can repeat and the method identical according to step 8-15, to melt the tissue around other renal artery in same operation process.

17. take out the INAS10 in its closed position from guide catheter.In closed position, pin 19 is packed, and can not injure medical personnel, or makes medical personnel be exposed to the pathogen that blood is propagated.

18. take out all residue apparatuses in body.

Similarity method can use together with INAS10, and to enter the guide catheter treatment atrial fibrillation in left atrium by inserting through interventricular septum, wherein the wall of target vessel is the wall of one of pulmonary vein.

Fig. 6 is the longitudinal cross-section figure of the distal part of another embodiment of nervus vasculairs ablation system of the present invention (INAS) 40, and described INAS40 sends on the wire 60 separating.Fig. 6 shows the INAS40 in its fully open position, and described INAS40 has from expansion syringe 45, and described have sharp-pointed far-end from expansion syringe 45, to form the pin 49 that is opened to its maximum gauge.Soft cotton rope 43 connects syringe 45 and serves as and penetrates limiting member, exceedes in ultimate range D intravasation wall to prevent that the distal tip of pin 49 from penetrating.Different from the rope 13 of Fig. 1, rope 43 enters and far-end distance B place by the hole 57 in the sidewall of each syringe 45.Binding agent (not shown) can be used for sealing hole and prevents melting material or solution leaks in blood vessel wall in injection process.

Shown sheath 42, in described position, it retracts, to allow the expansion completely of syringe 45.In this embodiment of INAS40, there are 4 syringes 45, lack to 2 and reach 12 syringes 45 although imagined.Distance B can be between 0.2-2mm, and wherein the best is about 0.5-1mm.

The near-end of syringe 45 is kept by manifold 47, and described manifold 47 is attached to the far-end inside of outer tube 46 and inner tube 48.Injecting cavity 51 is located between the inner tube 48 and outer tube 46 of nearside of manifold 47.The material that melts of injecting by injecting cavity 51 will flow in the near-end of syringe 45, and leaves subsequently entry needle 49, in the one or more layer of intravasation and/or enter just in time in the tissue volume of blood vessel wall outside.

The distal section 50 that is coaxially attached to the INAS40 of the distal section of inner tube 48 comprises taper flexible tip 56, radiopaque labelling 55 and sheath junction section 54, described sheath junction section 54 guarantees that at INAS40, for melting after the tissue of human vas, the distal part of INAS40 will suitably be withdrawn in sheath 42.Wire 60 can advance and be retracted to guidewire lumen 41 inside at longitudinal direction, and described guidewire lumen 41 is positioned at inner tube 48 inside.INAS40 can be constructed on line or quick exchange device.If on line, as shown in Figure 7, run to the near-end of INAS40 in the guidewire lumen 41 of inner tube 48 inside always.If use fast exchange configuration, wire will leave INAS40, and for the some parts of INAS40 length, in the operation of the outside in INAS40 outside.If use fast exchange, slit that need to be in sheath 42, to allow sheath 42 to vertically move with respect to the remainder of INAS40.Fast the near-end of exchange configuration will equal the near-end of static line INAS10 of Fig. 4.For recent side 10cm at least, wire is generally in the outside operation of INAS40 main body, and wherein preferred embodiment has the wire that leaves by the sidewall of outer tube 46 and the sheath 42 apart from INAS40 far-end 5-15cm.

Fig. 7 is the longitudinal cross-section figure of the near-end 70 of embodiment on the line of INAS40 of Fig. 6.Inner tube 48 has Rule accessory 78 that is attached to its near-end.Wire 60 can advance past the guidewire lumen 41 in inner tube 48 inside.The proximal attachment of outer tube 46 is to hub 79, and described hub 79 seals for inner tube 48, is formed on the injecting cavity 51 between inner tube 48 and outer tube 46.The side pipe 74 with chamber 76 is connected in hub 79 by Rule accessory 75, and described Rule accessory 75 is attached to the near-end of side pipe 74.Syringe or other injection devices can be attached to Rule accessory 75, enter in injecting cavity 51 by chamber 76 will melt material or injection of solution, enter in the syringe 45 of Fig. 6, and leave in the end intravasation wall of entry needle 49.The near-end of sheath 42 is connected to hub 77, and described hub 77 serves as handle with coaxial slip sheath 42 on outer tube 46, to open and to close the INAS40 of Fig. 6.The side pipe 72 with chamber 73 is connected in hub 77.Rule accessory 71 is attached to the near-end of side pipe 72, to allow before INAS40 introduces in human body, rinses the chamber 62 between sheath 42 and outer tube 46 with saline solution.Although the hub 77 showing is plastic members herein; but imagination can be used Tu Yi-Bo Site accessory herein; Tu Yi-Bo Site accessory 30 of for example Fig. 4; and can be favourable; because sheath 42 is locked onto in the position on outer tube 46 process that it allows to take out in insertosome and in body; make the far-end of sheath 42 will be retained in its farthest side position, protection entry needle 49 and protection medical personnel are not exposed to needle stick injuries.

Fig. 8 is the longitudinal cross-section of disposable syringe 90, and described syringe 90 is for providing the solution that melts that is heated to preset temperature to use for the INAS10 injection by Fig. 1-5C, to melt the tissue in human body.Syringe 90 comprises the syringe 104 with fluid storage volume 99 and recessed Rule accessory 93, and described recessed Rule accessory 93 is generally attached to standard plug valve (not shown), protruding Rule accessory 35 of the proximal end of the INAS10 that this plug valve is connected in Fig. 1-4.Also imagining plug valve can provide or be incorporated in any one together with syringe 90 or INAS10.Syringe 104 by heater coil 94 around, described heater coil 94 is included in the shell 95 that is full of thermal insulation barriers 96.Be used for the power of heater coil 94 from battery 98, described battery 98 has the positive pole 91 and the negative pole 92 that are contained in battery case 97.As shown in Figure 5 C, there is the removable thromboembolism 101 of handle 102 and distally gasket seal 103 for the heating ablation fluid injecting that adds of volume 99 is passed through to Rule accessory 93, enter in the INAS10 injecting cavity 21 of Fig. 4, in described injecting cavity 21, described in add heating ablation fluid and flow out subsequently the entry needle 19 by Fig. 1 and 3 and enter in tissue.Injecting cavity 90 can comprise having closed loop circuit or the one or more LED that temperature is shown, described closed loop circuit or LED allow user understand when to melt fluid in temperature required in syringe 104.Injecting cavity 90 can be manufactured for single preset temperature or be adjustable to and exceed a temperature.Although Fig. 8 shows manual injection thromboembolism 101, also imagine fluid pump or mechanical system that thromboembolism is depressed and can be incorporated in injecting cavity 90.By making normal benign substance cause the point of ablation of tissue as normal saline is heated to wherein heat, the purposes that adds hot fluid ablation tissue can be effectively, or heat can act on the ability that melts of improving for example ethanol of fluid conventionally melting under room temperature or body temperature.

Fig. 9 is the longitudinal cross-section figure of the proximal section of entry needle 110, and described entry needle 110 has chamber 111 and far-end 119, shows that attached longitudinal shape memory metal wire respectively with portions of proximal 112 and 113 penetrates limiting member 114 and 116.These portions of proximal 112 and 113 attached (gluing, welding or brazing) are to the outside 115 of pin, make in the time that pin 110 discharges from sheath 12 inside of Fig. 1-4, the distal part of line 114 and 116 will be taked its remember condition as shown in Figure 9, forms the member that restriction needle point 119 is penetrated into about preset distance L2.Because most of tremulous pulsies have similar thickness, so can being made as, distance L 2 guarantees that the fluid that melts of injecting by pin chamber 111 will occur in the tissue of suitable volumes.The selection of suitable volumes can be passed through the different value setting of L2, and injection can be made as in tunica media of artery, tunica adventitia of artery or tunica adventitia of artery outside.Although Fig. 9 shows two lines 114 and 116, single line also will act on restriction and penetrate, or also can use 3 or more lines.Ideally, one or more line will be attached to the outside of pin 115 on pin circumferential side wall, instead of on inside or outside, wherein, before sheath 12 retracts to launch pin, line 114 and 116 is by the diameter of the closed INAS10 of increase Fig. 1-4.

Also be designed to the supercool syringe melting in the INAS that fluid is delivered to Fig. 1-4 to be but also suitable for the application.

Importance of the present invention is to melt fluid-phase to send for the circumference of blood vessel wall.This type of that injects stomion from one or more sent must circumference and attack nervous tissue to guarantee effect at correct depth, and makes ideally health to inner membrance and middle rete and the damage of normal cell structure drop to minimum.Circumference is sent can be as mentioned above with three different modes processing.

1. in the three or more somes place injected into blood vessel wall around blood vessel circumference.

2. although be expelled to, at the Kong of blood vessel wall outside Nei –, this can pass through the realization of single needle/exit point, and this completes with at least two exit points best, makes pin can keep very little, to allow blood vessel wall to seal in the time that pin shrinks again.

3. be expelled to inner to fill annular gap and will melt fluid circumference and be delivered to the inner surface of blood vessel.

Figure 10 is the schematic diagram of the portions of proximal of neural ablation system (INAS) 200 in the blood vessel of the present invention another one embodiment in its fully open position, described INAS200 has fixing cord 225, and described fixing cord 225 has the tip 228 at its far-end.Figure 10 shows the INAS200 in its fully open position, and described INAS200 has from expansion syringe 215, and described have sharp-pointed far-end from expansion syringe 215, to form the entry needle 219 that is opened to its maximum gauge.In this embodiment, syringe 215 has dual turn of bilge or bending 214 separately, and described dual turn of bilge or bending 214 have in circumferential length L 4.Bending 214 is served as and is penetrated limiting member, exceedes in ultimate range L3 intravasation wall to prevent that the distal tip of pin 219 from penetrating.

The sheath 212 with radiopaque labelling 227 is shown in Figure 10, and in described position, it has retracted to allow the expansion completely of syringe 215.In this embodiment of INAS, there are 3 syringes 215.The distal section 220 of INAS200 comprises fixing distally line 225, taper flexible tip 226, radiopaque labelling 224 and sheath junction section 222, described sheath junction section 222 guarantees that at INAS200, for melting after the tissue of human vas, distal part will suitably be withdrawn in sheath 212.What Figure 10 also showed is the outer tube 216 with injecting cavity 221 and heart yearn 211.The INAS200 of Figure 10 is by use to the identical mode of the INAS10 of 5E with Fig. 1, and wherein difference is to use bending (dual turn of bilge) 214 as penetrating limiting member.Compare with the limiter that penetrates of Fig. 1-5E that is attached to syringe, bending 214 is incorporated in syringe 215.Adding bending 214 should be the material of dual turn of bilge being arranged to the shape of memory metal (for example NITINOL) pipeline, and described pipeline is used to form each in syringe 215, and described syringe 215 has the sharp-pointed end that forms entry needle 219.In this embodiment, syringe self limits penetrating in the wall that enters target vessel.For being shaped and heat treatment NITINOL pipeline is well-known so that the process of memory to be set.

The present invention has discussed INAS for melting the purposes of tissue of human body.It also has advantages of the intravascular injection for any fluid or medicine.The ability of restriction penetration depth allows it by film, adventitia or adventitia outside in any fluid selectivity injected into blood vessel.The use that the dual turn of bilge of also imagining Figure 10 penetrates limiting member concept can be applicable to wherein need to inject a fluid at preset distance place the in-house any application of people.

Term circumference is sent simultaneously injected at least three points that are defined as herein at blood vessel wall inner periphery interval, or fills at the circumference in the outside space of tunica adventitia layer (outer wall).

Figure 11 is the longitudinal cross-section of another embodiment of INAS300 of the present invention in its closed position, and described INAS300 has four syringes 316, and described four syringes 316 can have four interior slips of guiding tube 315 can expanding distal part.The syringe 316 with prong 319 has near the injection outlet port 317 far-end of each syringe 316.Sheath 312 encapsulation with distally radiopaque indicia band 327 have the guiding tube 315 of coaxial syringe 316.Syringe 316 has injecting cavity 321.In syringe 329, the far-end of each is taper, with at guiding tube 315 in expansion process during to external expansion, provide by with the surface of blood vessel wall almost parallel.The distal part with the guiding tube 315 of length L 5 is made as the shape memory of expansion, and is subject to as shown in figure 11 sheath 312 to retrain to prevent expansion.Four guiding tubes 315 are not attached to or are connected to the heart yearn 311 in distance L 5.At distance L 5 nearsides, guiding tube 315 is attached to or is connected to heart yearn 311, and wherein preferred embodiment is shown in Figure 13, and wherein heart yearn 311 and four guiding tubes 315 embed in plastic cylinder 305.

INAS300 far-end has and is attached to can the be shaped tapered segment 326 of fixing cord 320 of distally, and described fixing cord 320 has solderless wrapped connection outside 325, heart yearn 311 and most advanced and sophisticated 328.Tapered segment 326 comprises radiopaque labelling 324 and nearside bullet 323, to be conducive to launching to melt fluid injecting to after in blood vessel wall at INAS300, closes sheath 312 in proximal section 323.

Figure 12 is the amplification of the region S12 of the INAS300 of Figure 11, shows the guiding tube 315 of coaxial positioning in sheath 312 inside.The distal part coaxial positioning of syringe 316 is in the inside of distal part of guiding tube 315 with tapered distal end 329, and the distal part of described syringe 316 has prong 319, chamber 321 and injection outlet port 327.All or part of of pin 319 or one or more whole syringe can be made up of radiopaque material for example tantalum, platinum or gold.Also imagining the end of pin can or be electroplated by for example gold of radiopaque material by for example gold coating of radiopaque material, or before in truncation becomes cutting needle, platinum insert is placed in the distal tip of syringe.What also show is heart yearn 311 and the proximal section 323 of tapered segment 326.The distal part of also imagining the far-end 329 that comprises guiding tube 315 also can be made up of for example gold of radiopaque material, by for example gold coating of radiopaque material or by for example gold plating of radiopaque material.

Figure 13 is the circle type cross section at the S13-S13 place of the INAS300 of Figure 11, clearly shows four the outside guiding tubes 315 that are attached to heart yearn 31.There are syringe 316 coaxial positioning of injecting cavity 321 in the inside of guiding tube 315.Syringe 316 is free to slide in a longitudinal direction at the intracavity of guiding tube 315.Syringe 316 also can be formed and preform by Nitinol, with the bending distally shape of directed parallel pipe 315, to strengthen the coaxial movement of syringe 316 in guiding tube 315.Guiding tube 315, syringe 316 and heart yearn 311 are coaxially positioned at sheath 312, and described sheath 312 is free to slide in these parts.Also show how guiding tube 315 and heart yearn 311 embed in plastics 305, so that this part keeps together better, or they can connect by the use of welding, brazing or binding agent.The use of plastics 305 also allows cylindrical surface, and the portions of proximal of sheath 312 can be for described cylindrical surface sealing, to allow, before device use starts, using the space of normal saline washing between the inside of sheath 312 and the outside of plastics 305.

Figure 14 is the expansion distal part of the INAS300' longitudinal cross-section in complete open configuration, and wherein syringe 316 shows and advances the far-end that exceeds guiding tube 315.The far-end of syringe 316 has prong 319, and described prong 319 has injection outlet port 317.

In this configuration, sheath 312 has been pulled, to allow guiding tube 315 to external expansion.Guiding tube 315 is generally made up of for example NITINOL of memory metal.Syringe 316 can be made up of for example 316 level of surgery rustless steels of any metal, or also can be made up of NITINOL or for example tantalum of radiopaque metal or platinum.If element 315 and 316 be can't help the manufacture of radiopaque metal, the distal part of imagining one or more syringes 316 and one or more guiding tube 315 will be by for example gold coating of radiopaque material, general near the far-end of one or more pipes or the far-end at one or more pipes, or a slice radiopaque material can be used for forming prong 319, or near the prong 319 of the far-end at syringe to be positioned.Diameter L6 instruction is used for the memory configuration of the guiding tube 315 of opening completely.For the use in renal artery, L6 is generally 3-10mm, if only prepare a size, 8mm is optimum configuration, because only a few renal artery is greater than 7mm diameter.What also in Figure 14, show is the far-end 329 of guiding tube 315, and it is parallel with the longitudinal axis of INAS300' in complete open configuration.The distal part of INAS300' has the tapered segment 326 that is attached to fixing cord 320, and described fixing cord 320 has tip 328, skin 325 and heart yearn 311.

Figure 15 is the amplification of the region S15 of Figure 14, because it shows the syringe 316 with chamber 321, and distal needle 319 advances the far-end 329 that exceeds guiding tube 315 completely.What also in Figure 15, show is arterial wall, and described arterial wall has internal elastic membrane (IEL), middle film, external elastic membrane (EEL) and adventitia.Figure 14 shows that injection outlet port 317 is placed in the heart of adventitia.

The key character of INAS300 of the present invention is can adjust like this about the penetration depth of the injection that exports port by injection, makes to realize any in following.

1. be expelled in middle film.

2. being placed in each by one of injected current being appeared is expelled in film and adventitia.

3. be expelled to as shown in figure 15 in adventitia,

4. be expelled in the volume of adventitia and adventitia outside, and

5. be only expelled in the volume of adventitia outside.

Particularly, the distance L 7 that the tip of pin 319 extends beyond the end 329 of guiding tube 315 can be used the apparatus in the near-end of INAS300 to adjust.

Figure 16 is the longitudinal cross-section of the near-end of the INAS300 of Figure 11-15.Three handles, nearside injection handle 330, central guiding tube handle 340 allow sheath 312, guiding tube 315 and the relative of syringe 316 to vertically move with distal sheath joystick 350.Have the sheath joystick 350 in its recent side position for the position shown in Figure 16, described recent side position has retracted instruction sheath 312 in proximal direction completely, and this will allow guiding tube 315 as shown in figure 14 to external expansion.Use has the screw of screw thread 335 and adjusts small pieces 334, and capable of regulating has the gap of distance L 8 between injection handle 330 and guiding tube handle 340, and described screw thread 335 allows screw adjustment small pieces 334 to move with respect to the portions of proximal 333 of injection handle 330.As the gap L 8 arranging enters the pin 319 of restriction syringe 316 and injection outlet port 317 penetrating in the wall of target vessel.Ideally, can inject labelling scale in the portions of proximal 333 of handle 330 at nearside, make medical science practitioner that gap L 8 can be set, and therefore adjust and penetrate distance.Have that to approach pipe Rule accessory 338 of 336 be that described handle central chamber 332 is communicated with chamber 321 fluids of syringe 316 for melting fluid injecting to the port in handle central chamber 332.

Central authorities' guiding tube handle 340 comprises Outboard Sections 342, containment member 344, described containment member 344 seals distal part and the Outboard Sections 342 of heart yearn 311, and four holes are provided, four syringes 316 can slide in the near-end of guiding tube 315 by described four holes.Rule accessory 348 with approaching pipe 346 provides by the hole in guiding tube 347, to approaching of the space between syringe 316 and guiding tube 315.

Distal sheath joystick 350 comprises distal part 354, and described distal part 354 use Rule accessories 358 and side pipe 356 are attached to the outside of sheath 312, provide to the chamber under sheath 312 approach, to allow described chamber to use normal saline washing before operation starts.Handle 350 also has portions of proximal 352 and elastic washer 359, by portions of proximal 352 being screwed into the interior compression elastic washer 359 of distal part 354, to lock the position of sheath 312 with respect to guiding tube 315.

Figure 17 is the amplification of the region S17 of Figure 16, shows the injection handle 330 that is attached to the side pipe 336 with chamber 331 by nearside Rule accessory 338.Portions of proximal 333 is for the outside seal of side pipe 336, and for the outside seal of four syringes 316.This sealing can be by binding agent or by plastotype on pipe 336 and 316 or formation nearside small pieces.The chamber 331 of side pipe 336 is communicated with central chamber 332 fluids of portions of proximal 333, and described central chamber 332 is communicated with chamber 321 fluids of syringe 316.Therefore, the fluid that melts of injecting by Rule 338 will flow in the chamber 321 of syringe 316, and the injection outlet port 317 by shown in Figure 15 is appeared in the tissue in target vessel wall or near tissue target vessel wall.Adjust small pieces 334 screw thread 335 on both and allow to adjust the gap L 8 of Figure 16 at the injection portions of proximal 333 of handle 330 and screw.As the gap L 8 arranging enters the pin 319 of restriction syringe 316 and injection outlet port 317 penetrating in the wall of target vessel.Ideally, can be in the portions of proximal 333 of injection handle 330 labelling scale, make medical science practitioner that gap L 8 can be set, and therefore adjust and penetrate distance.

Figure 18 is the amplification of the region S18 of Figure 16, shows central guiding tube handle 340 and sheath joystick 350.

Central authorities' guiding tube handle 340 comprises Outboard Sections 342, containment member 344, and the distal part of guiding tube 315 and heart yearn 311 is attached to Outboard Sections 342 by described containment member 344.Outboard Sections 342 seals for plastics 305, and guiding tube 315 and heart yearn 311 embed in described plastics 305.At the nearside of plastics 305 near-ends, have shown in Rule accessory 348(Figure 15 that approaches pipe 346) provide by the hole 347 in guiding tube 315, to approaching of the space between syringe 316 and guiding tube 315.

Distal sheath joystick 350 comprises distal part 354, shown in described distal part 354 use Rule accessory 358(Figure 15) and side pipe 356 be attached to the outside of sheath 312, provide to the chamber between sheath 312 and plastics 305 approach, to allow described chamber to use normal saline washing before operation starts.Handle 350 also has portions of proximal 352 and elastic washer 359, by portions of proximal 352 being screwed into the interior compression elastic washer 359 of distal part 354, to lock the position of sheath 312 on plastics 305.In this latched position that INAS300 closes as shown in figure 11 therein, INAS300 is advanced in main body, until the far-end of the indicia band 324 of Figure 11 is in renal artery.Unclamp subsequently portions of proximal 352, sheath joystick 350 can be pulled in distal direction, make central guiding tube handle 340 keep fixing simultaneously.Imagination ought be as shown in figure 18, and when the far-end of the Outboard Sections 342 of the near-end contact guidance pipe handle 340 of sheath joystick near-end small pieces 352, sheath 312 will shrink to allow the wall expansion of guiding tube 315 for target vessel completely.

Use INAS300 as follows for the complete operation of kidney denervation:

1. sterilized INAS300 is fetched into aseptic area from its packaging, with the injecting cavity 321 of normal saline washing syringe and the space between sheath 312 and plastics 305 and syringe 316 and guiding tube 315.

2. approach aorta via femoral artery, generally follow the insertion of guiding sheath.

3. use Fig. 5 A to the guide catheter 80 of 5E or there is the guide sheath of sharp-pointed far-end, engaging the first targeting renal artery by aorta.This can be confirmed by contrast-medium injection as required.

4. the far-end of INAS300 is placed in the near-end of guide catheter with the closed position of its Figure 11.General Tu Yi-Bo Site the accessory that has the far-end that is attached to guide catheter 80, loses blood to retrain.

5. Tu Yi-Bo Site accessory that the INAS300 of closure promotes subsequently by opening enters in guide catheter.

6. advance INAS300 by guide catheter, until the distally of the guide catheter far-end of indicia band 324 in renal artery.

7. retract sheath 312 in proximal direction, make guiding tube handle 340 keep fixing simultaneously.As shown in figure 15, this will allow syringe 315 to expand for arteriorenal wall.

8. sheath joystick 350 is locked onto downwards on plastics 305.

9. Tu Yi-Bo Site accessory of the proximal end at guide catheter is locked onto downwards on sheath 312.

10. advance guiding tube handle 340, also outwards open with arteriorenal wall good contact with the far-end 329 of guaranteeing guiding tube 315, to vertically point to more closely the long axis of renal artery wall.

11. make guiding tube handle 340 keep fixing in, advance injection handle 330 until the near-end of its far-end contact guidance pipe joystick 340.This enters the far-end 329 that impels pin 319 to advance past guiding tube 315 in the wall of target vessel, to suitable the penetrating of two handles, 330 and 340 restrictions that contacted.

Syringe or injecting systems are attached to Rule accessory 338 by 12., and described syringe or injecting systems provide the fluid that melts being expelled in arteriorenal wall.Can be optionally melting before fluid injecting anesthetic medicine as lignocaine and/or contrast medium, to prevent or reduce the pain relevant with operation and/or guarantee that pin in place.Also imagine anesthetics or contrast agent can with melt combination of fluids.

13. by suitable volumes melt fluid from the injection of syringe or injecting systems by the chamber 321 of syringe, and leave that injection outlet port 317 enters in renal artery wall and/or in the outside of renal artery wall.General injection will be 1-10ml.Shown in zone of ablation as shown in Fig. 5 D and 5E, this should produce multiple crossing ablated volume (for one, every pin), and described ablated volume should be created in renal artery circumference ablation tissue anchor ring around.

14. make guiding tube handle 340 keep fixing simultaneously.Injection handle 330 is pulled in proximal direction, pin 319 is retracted in guiding tube 315.

15. make sheath joystick 350 from plastics 305 releases, and make guiding tube handle 340 keep fixing simultaneously, advance sheath joystick 350 in distal direction, until guiding tube 315 is gone back in the far-end of sheath 312 completely, and indicia band 327 and 324 abuts one another, INAS300 is now in its closed position as shown in figure 11 in instruction.

16. can repeat and the method identical according to step 6-15, to melt the tissue around other renal artery in same operation process.

17. take out the INAS300 in its closed position from guide catheter.In closed position, pin 319 dual packaged are in guiding tube 315, and described guiding tube 315 is in sheath 312 inside, and therefore prong 319 can not injure medical personnel, or make medical personnel be exposed to the pathogen that blood is propagated.

18. take out all residue apparatuses in body.

Similarity method can use together with INAS300, and to enter the guide catheter treatment atrial fibrillation in left atrium by inserting through interventricular septum, wherein the wall of target vessel is the wall of one of pulmonary vein.

Figure 19 is the longitudinal cross-section of the portions of proximal of the alternate embodiments of INAS400, compares with the INAS300 portions of proximal of Figure 16, and described INAS400 simplified design.INAS400 uses the distal part design identical with the INAS300 of Figure 11-15.Three handles, nearside injection handle 430, central guiding tube handle 440 allow sheath 312, middle pipe 415 and inner tube 416 to vertically move for the relative of injecting cavity 421 with distal sheath joystick 450.Have near the sheath joystick 450 its recent side position for the position shown in Figure 19, described recent side position has retracted instruction sheath 312 in proximal direction completely.In this position, identical with the INAS300 of Figure 11-18, this by the distal part that causes guiding tube 315 as shown in figure 14 to external expansion.

Use has the screw of screw thread 435 and adjusts small pieces 434, and capable of regulating has the gap of distance L 9 between injection handle 430 and guiding tube handle 340, and described screw thread 435 allows screw adjustment small pieces 434 to move with respect to the portions of proximal 433 of injection handle 430.It is to penetrate limiting member that screw is adjusted the near-end of small pieces 434, and penetrating with the injection outlet port 317 of syringe 316 of restriction pin 319 entered the distance L 9 in the wall of target vessel by it.Ideally, can inject labelling scale in the portions of proximal 433 of handle 430 at nearside, make medical science practitioner that gap L 9 can be set, and therefore adjust and penetrate distance.The central canal 416 with chamber 421 are sealed in the nearside small pieces 433 of distally injection handle 430.Have that to approach pipe Rule accessory 438 of 436 be for melting fluid injecting to the port in handle cavity 432.The chamber 439 of Rule accessory 438 is communicated with chamber 437 fluids that approach pipe 436, and described chamber 437 is communicated with injecting cavity 421 fluids of inner tube 416.Inner tube 416 is generally metal hypotube, although also imagined plastic tube or had litzendraht wire or the plastic tube of helix strengthening.

Be attached to pipe 415 and control in manage 415 the central guiding tube handle 440 vertically moving and comprise portions of proximal 444, described portions of proximal 444 can be screwed in distal part 442.When being screwed into distal part 442 when interior, portions of proximal 444, by compression washer 445, allows handle 440 to lock onto on middle pipe 415 downwards.In the time that Rule accessory 448 with side pipe 446 can be used for rinsing the space between inner tube 416 and middle pipe 415 with saline solution, this is also required in the process for the preparation of using.

The distal sheath joystick 450 vertically moving that is attached to sheath 312 and control sheath 312 comprises portions of proximal 454, and described portions of proximal 454 can be screwed in distal part 452.When being screwed into distal part 452 when interior, portions of proximal 454, by compression washer 455, allows handle 450 to lock onto on sheath 312 downwards.In the time that Rule accessory 458 with side pipe 456 can be used for rinsing the space between middle pipe 415 and sheath 312 with saline solution, this is also required in the process for the preparation of using.

Figure 20 is the longitudinal cross-section of central transition portion 460, and described central transition portion 460 connects the portions of proximal of INAS400 of Figure 19 and the distal part of the INAS300 of Figure 11-15.The near-end of central authorities' transition portion 460 comprises identical three concentric tubees of the far-end of the handle portion that is positioned at the INAS400 shown in Figure 19.Particularly, the near-end of transition portion 460 comprises inner tube 416, middle pipe 415 and the sheath 312 with injecting cavity 421.At the far-end of inner tube 416, insert manifold 410, inner tube 416 is sealed to four syringes 316 by it, and the chamber 421 of inner tube 416 and chamber 321 fluids of four syringes 316 are communicated with.In addition, therefore the lengthwise movement of inner tube 416 will change the lengthwise movement of four syringes 316 into.

Middle pipe 415 is sealed in the inside of plastic member 405, and described plastic member 405 is also sealed to guiding tube 315 and heart yearn 311.The lengthwise movement of middle pipe 415 will change the lengthwise movement of four guiding tubes 315 into.Sheath 312 is sheaths identical with the distal part of the INAS300 of Figure 11-15.

Figure 21 is the circle type cross section at the S21-S21 place of the central transition zone 460 of Figure 20.Watch visible three concentric tubees in cross section: sheath 312, middle pipe 415 and inner tube 416 in distal direction.At the inner visible near-end of manifold 410 of inner tube and the near-end of four syringes 316.Also clear and definite visible manifold 410 is sealed to four syringes 316 in inner tube 416, and the chamber 421 of inner tube 416 is led in the chamber 321 of syringe 316.

Figure 22 is the circle type cross section at the S22-S22 place of the central transition zone 460 of Figure 20.Watch visible sheath 312 and middle pipe 415 in cross section in distal direction.Middle pipe 415 is sealed in the distal part of plastic member 405.Be also shown in the near-end of four guiding tubes 315 and heart yearn 411.Also show how four syringes 316 enter the near-end of guiding tube 315.

Figure 23 is the circle type cross section at the S23-S23 place of the central transition zone 460 of Figure 20.This cross section equals the circle type cross section shown in Figure 13, shows that sheath 312 and plastic member 405(are 305 in Figure 13), described plastic member 405 seals four guiding tubes 315 and heart yearn 311, and together with four guiding tubes 315 are attached to heart yearn 311.Syringe 316 is positioned at the inside of four guiding tubes 315 concentrically.Figure 20-23 clearly show how the simplification near-end of Figure 19 is connected to the distal part of the INAS300 of Figure 11-15.

Figure 24 is the longitudinal cross-section of the near-end of the alternate embodiments of INAS500, described INAS500 has syringe 516, described syringe 516 has coring needle 519, and described coring needle 519 has the radiopaque line 518 at its intracavity, so that the visual of pin to be upon deployment provided.Radiopaque line 518 generally extends beyond the near-end of syringe 515, and they will be attached to the structure of INAS500 therein.Although preferred configuration has simply the radiopaque line 518 at the intracavity of syringe 516, also imagines radiopaque line and can use binding agent or brazing to be fixedly attached to syringe inside.If use this type of attached, radiopaque line can be shorter than syringe 516 and be arranged in farthest side part.

In this embodiment, injection outlet port 517 is at the far-end of coring needle 519.In this configuration, sheath 512 has been pulled to allow guiding tube 515 to external expansion.Guiding tube 515 is in this embodiment made up of one or two plastic layer, and described plastic layer is pre-formed with the curved shape of expansion.Syringe 516 can be made up of any metal, and described metal is 316 level of surgery rustless steels, NITINOL or for example tantalum of radiopaque metal or platinum for example.In this embodiment, the distal part of each guiding tube 516 has radiopaque section 522, and described radiopaque section 522 is integrated and formed with guiding tube, and the polyurethane of generally being filled by for example barium of radiopaque plastics or tungsten forms.What also in Figure 24, show is the far-end 529 of guiding tube 515, and described guiding tube 515 is parallel with the longitudinal axis of INAS500 at diameter L10 place in its complete open configuration.For the use in renal artery, L10 is generally 3-10mm, if only prepare a size, 8mm is optimum configuration, because only a few renal artery is greater than 7mm diameter.

The far-end 529 of guiding tube is contacted as far as possible closely, is important to flatten for arteriorenal inside, because if angle is too sharp-pointed, and pin 519 arterial wall that may suitably not puncture.When plastics are also so when the guiding tube 515, although form with curved shape, when retracting in sheath time expand when section, this shape variable obtains slightly and stretches.For this reason, imagination INAS500 will open configuration packaging with it, to reduce guiding tube time in rectilinear form in sheath.

The original shape that also proposes guiding tube 516 will have end 529, and in fact described end 529 is shaped with fully open position, with also more bending backward than the degree of 90 shown in Figure 14 and 24.For example, if start angle is 135 degree in the time of 8mm diameter, this is the INAS500 that opens the completely position in the time forming, and, in the time of 7mm diameter, angle can be 120 degree, and at 6mm time-105 degree, at 5mm time-90 degree, during at 4mm time-75 degree with at 3mm, 60 spend.Therefore, the blood vessel for diameter between 3-7mm, pin 519 will engage blood vessel wall between 60-120 degree.Therefore, in this example, Figure 24 will be that INAS500 is in the endovascular shape of 5mm diameter.

The distal part of INAS500 has tapered segment 526, and described tapered segment 526 is attached to the fixing cord 520 with most advanced and sophisticated 528, and described fixing cord 520 has skin 525 and heart yearn 511.Also show the far-end of the sheath 512 with distally radiopaque labelling 513.The zoomed-in view of section S26 is shown in Figure 26.

Figure 25 A is the amplification of the region S25 of Figure 24, because it shows the syringe 516 with chamber 521, and distal needle 519 advances the far-end 529 that exceeds guiding tube 515 completely.Radiopaque line 518 is in the interior clearly demonstration in the chamber 521 of syringe 516.Syringe 516 generally will be less than 25 gage needle, and in diameter, be less than 0.015 ideally ", its lumen 521 is at least 0.008 in diameter ".Therefore, radiopaque line 518 must enough be less than the diameter in chamber 521, to do not hinder injection, but in diameter still enough greatly with visible in fluoroscopy FAXIA.Therefore, the ideal noise diode of 0.002 " 0.006 " should work, and wherein the diameter of 0.004 " 0.005 " is desirable.Preferred outside and inside diameter about syringe 516 will be 0.012 " 0.014 ", and its lumen 521 is between 0.008 " and 0.010 ".

In addition, shown guiding tube 515, it has interior elastic layer 527, outer elastic layer 531 and radiopaque labelling 522.Radiopaque labelling 522 is presented at plastotype on inner plastic layer 527 herein, and described inner plastic layer 527 is in the distally of the end of outer plastic layer 531.Radiopaque labelling 522 should grow to few 0.5mm, and wherein 1-2mm is preferred.For example, inner plastic layer 527 can be polytetrafluoroethylene or polyimides, and skin 531 can be softer for example polyurethane of plastics or tecothane.Ideally, the far-end 529 of guiding tube 515 will be enough soft, when it contacts in expansion process with box lunch, reduce the danger that penetrates of blood vessel wall.Also imagine the far-end that the metal tape being made up of gold, platinum or tantalum also can be used for labelling guiding tube 515.Also imagination outer 531 and radiopaque labelling 522 can be identical, and making whole guiding tube 516 will be visible in fluoroscopy FAXIA.

The use of radiopaque line 518 also reduces the dead space in syringe 516, is important because make volume in whole INAS500 drop to minimum, and wherein volume of ideal is less than 0.2ml.This will be conducive to reduce for PVRD the injecting method of time, and described PVRD will be by starting with normal saline washing INAS500.

A kind of technology that is envisioned for arbitrary interior dead space in the injecting cavity that reduces INAS is to have line in intracavity portion, as the line 518 in 521 inside, chamber, to occupy volume.Similarly, line can insert in the chamber 421 of inner tube 416 of Figure 20, to occupy the volume in chamber 421.

Once pin is through the position of renal artery wall, just by the fluid that melts of infusion of suitable amount therein.Subsequently will the enough saline of injection, so that all fluids that melt are rinsed leave INAS500 completely.INAS500 will close, and the second renal artery is processed in the same manner.INAS500 will take out subsequently in body.The radius of curvature R 1 of the distal part of syringe 516 should be roughly the same with the radius of curvature R of guiding tube 515 2.This will prevent that guiding tube 515 nearsides move (falling back) in the time of pin 519 puncture vessel wall.Therefore, R1 and R2 should be in 2mm each other.If also imagination radius of curvature is significantly different, radius of curvature R 1 should be less than R2.

In fact, the radius of curvature of the distal part of each guiding tube 515 will change with blood vessel diameter, larger for less blood vessel, and described less blood vessel, by confinement tube 515, does not allow them to open completely.Therefore, ideally, each syringe 516 comprises that the radius of curvature of the distal part of entry needle 519 should be with in the time that guiding tube 515 expands to its maximum gauge, and the radius of curvature of the distal part of guiding tube 515 is identical.

Pin 519 extends beyond far-end 529 distance L 11 of guiding tube 515.This distance is generally 2-4mm, and wherein preferred distance is 2.5,3.0 and 3.5mm, supposes that INAS500 distance L 11 is preset in factory.

Figure 25 B is the alternate embodiments of the distal section S25 of the INAS500 of Figure 24.Figure 25 B has the structure about syringe 516 identical with Figure 25 A, and described syringe 516 has entry needle 519, and described entry needle 519 has injection outlet 517 and radiopaque line 518.With the difference of Figure 25 A be the instrument for the radiopaque labelling of guiding tube 515.In Figure 25 B, guiding tube 515 also has internal layer 527 and has the skin 531 of far-end 529.Metal radiopaque indicia band 505 is attached to the outside of guiding tube 515 close to far-end 529.The combination of metal tape 505 and radiopaque line 518 provides the good combination of the key component for manifesting INAS500, suitably locate before fluid is melted in injection to guarantee injection outlet 517, described metal tape 505 shows the far-end of guiding tube 515, and described radiopaque line 518 shows the extension of the syringe 516 with entry needle 519.

Figure 26 is proximal section 540(or the handle of INAS500) the schematic diagram of embodiment, described INAS500 has by the locking mechanism can pressing button 532 and 542 activating.Particularly, in the time depressing, button 532 release sheath control cylinder 535 motions with respect to guiding tube control cylinder 533.Sheath control cylinder 535 is attached to sheath 512 by transition zone 538.Guiding tube control cylinder 533 is attached to the middle pipe 505 of Figure 28, and described middle pipe 505 is connected to again Figure 24,25 and 28 guiding tube 515 successively.Sheath control cylinder 535 comprises recess 531, and described recess 531 is for limiting sheath 512 retracting in nearside distance.

In the time depressing, button 542 is separated the motion of purl control cylinder 545 with respect to guiding tube control cylinder 533.

Handle 540 has two irrigation ports.The port 534 generally with Rule accessory shows together with lid 536.Port 534 is for the space 507 between sheath 512 and pipe 505 shown in normal saline washing Figure 28, and space between sheath 512 and guiding tube 515.The injection port 544 generally with Rule accessory shows together with lid 546.Port 544 is for the space 508 between pipe 505 and inner tube 506 with normal saline washing.The port 554 generally with Rule accessory shows together with lid 556.Port 554 allows to melt fluid injecting in the chamber 521 of Figure 28, and described chamber 521 is communicated with the chamber fluid of syringe 516.

Handle 540 also comprises gap adjustment cylinder 548, and cylinder 548 is adjusted when with a direction rotation in described gap, and minimizing entry needle 519 extends beyond the distance of the end of guiding tube 515.Cylinder 548 extends beyond increase entry needle 519 with another direction rotation the distance of the end 529 of guiding tube 515.It can be come-at-able for the user of INAS500 that cylinder is adjusted in imagination gap, and wherein the labelling on handle 540 is indicated distance to be reached.In a preferred embodiment, gap is adjusted cylinder 548 and only can in the assembling of INAS500 and test process, can be approached, preset in factory in the Computer-Assisted Design, Manufacture And Test process of each INAS500 to guarantee the distance L 11 of suitable correction of Figure 25.This ability of correction distance L11 is crucial for the good yield in manufacture process.In other words,, even have several millimeters of variations in for example inner tube 506 of parts of INAS500 and the relative length of middle pipe 505, it is tuning definitely that distance L 11 can be used gap to adjust cylinder 548.In this preferred embodiment, INAS500 will carry out labelling according to the preset distance L11 shown in Figure 25.For example, INAS500 can be configured to have three different distance L11 of 2.5mm, 3mm and 3.5mm.Also imagination can comprise unshowned dog screw or other mechanisms, is locked in required separation distance placement gap is adjusted to cylinder 548 after correction.Show herein although cylinder 548 is adjusted in gap, imagine for example sliding cylinder body of other mechanisms and also can be used for adjusting distance L 11.

Handle 540 operates INAS500 and will comprise the steps: for the function of PVRD

1. whole by the internal volume of port 534,544 and 554 use normal saline flushing INAS500.

2. INAS500 is inserted through to the guide catheter of previous placement, described guide catheter is arranged on INAS500 distal part at the desired location place in patient's a renal artery.

3. press push button 532, and keep pin control cylinder 545, described pin control cylinder 545 locks onto guiding tube control cylinder 533, pulls sheath control cylinder 535 in proximal direction simultaneously, until recess 531 engages port 544, limit retracting of sheath 512.

4. release-push 532, described button 532 locks the relative motion of sheath control cylinder 535 with respect to guiding tube control cylinder 533 again.

5. press push button 542, described button 542 discharges the relative motion of entry needle control cylinder 545 with respect to guiding tube control cylinder 533, and keep sheath control cylinder 535 simultaneously, described sheath control cylinder 535 locks onto guiding tube control cylinder 533 now, propelling has the pin control cylinder 545 of far-end 549, until penetrate limiting member stop motion, and preset pin 519 is with respect to the degree of depth L11 of the far-end 529 of guiding tube 515.This can complete in two ways: the far-end 549 that 1) promotes forward pin control cylinder 545, until it engages guiding tube irrigation ports 544, or 2) as shown in figure 26, the near-end that cylinder 548 is adjusted for gap in internal clearance 547 is closed, and cylinder 548 is adjusted in pin control cylinder 545 inside in described gap.

6. release-push 542, described button 542 locks the motion of entry needle control cylinder 545 to guiding tube control cylinder 533 again.

7. in this position, syringe or the manifold (not shown) with syringe can be attached to port 554, and inject the volume required fluid that melts.For example, injectable 0.2ml ethanol.If need to verify the position of INAS500 pin 519, can carry out angiography, watch arteriorenal length downwards, make visible radiopaque ring 513 and 524 on far-end and the tapered distal end 520 of sheath 512 concentrically, the outside of the radiopaque labelling on guiding tube 522, and extend in arteriorenal wall and all spaces of intravasation in, the distal part of syringe 516 has inner radiopaque line 518.This can together with or do not complete in renal artery together with contrast-medium injection.

8. next the syringe with normal saline solution is attached to port 554, replaces and melt fluid injector.Ideally, injection, than the slightly more saline of the cumulative volume of dead space, is melted fluid to guarantee not stay in INAS500.For example, if the dead space in INAS500 is 0.1ml, 0.12-0.15ml saline will be good amount, to guarantee that melting fluid is all delivered to suitable tissue blood vessel Zhou Tiji.

9. press push button 542 and simultaneously keep sheath control cylinder 535, retracts pin control cylinder 545 in proximal direction, until entry needle 519 is fully retracted to guiding tube 515 inside.To there is ratchet mechanism or block piece in imagination, in the time that entry needle control cylinder 545 arrives tram, entry needle 519 is shunk completely.

10. release-push 542, the motion of locking entry needle control cylinder 545 to guiding tube control cylinder 533.

11. press push button 532, discharge sheath control cylinder 535 relative motioies with respect to guiding tube control cylinder 533, and described guiding tube control cylinder 533 locks onto entry needle control cylinder 545 now.

12. advance sheath control cylinder 535 in distal direction, make entry needle control cylinder 545 keep fixing simultaneously.This will close INAS500, and guiding tube 515 is gone back in sheath 512.

13. are withdrawn into INAS500 in guide catheter.

Guide catheter is moved to other renal artery by 14..

15. for other renal artery repeating steps 3 to 13.

16. take out INAS500 in body.

Although button 532 and 542 cylindrical motion of release control in the time depressing as mentioned above, and in the time discharging, cylinder is controlled in locking, also imagines their also interlockings as follows:

1. the first interlocking allows entry needle control cylinder 545 only in sheath control cylinder 535 just release during in its farthest side position, and in described farthest side position, sheath 512 is pulled and guiding tube 515 launches completely.

2. the second interlocking allows sheath control cylinder 535 only in entry needle control cylinder 545 just release during in its farthest side position, and in described farthest side position, pin 519 is retracted in guiding tube 515.

Button 532 and 542 and the combination of above-mentioned controlling organization should make the use of INAS500 become simple and fool proof.Substantially pressing button 532 and sheath 512 is retracted, discharges guiding tube 515 with to external expansion, subsequently pressing button 542 and advance pin 519 forward to penetrate arteriorenal wall.Carry out injection, do conversely subsequently, button 542 is depressed and shunk pin 519, press push button 532 and promote sheath 512 forward subsequently, folding guide pipe 515 and close INAS500.

Figure 27 is the schematic diagram of the pin section of another embodiment of INAS550 of the present invention, described INAS550 has heart yearn 561 and non-circular cross sections guiding tube 565, described heart yearn 561 is formed by three twisted wire 561A, 561B and 561C, and described non-circular cross sections guiding tube 565 has radiopaque distal section 572 and far-end 579.INAS550 is similar to the INAS500 of Figure 24 slightly.It has containing the sheath 512 of distally radiopaque labelling 513, contains distally entry needle 569 and inject the syringe 566 that exports port 567.Tapered distal section 580 has tapered segment 576, radiopaque labelling 574 and proximal section 573.Significant is the curved shape backward with the syringe 566 of entry needle 569 in this embodiment.Particularly, the radius of curvature of syringe 566 should be mated or be slightly less than the radius of curvature of (more bending) guiding tube 565 and guiding tube distally radiopaque section 572.This will prevent in the time that pin 569 penetrates the wall of target vessel, comprises the stretching of guiding tube 565 of distally radiopaque section 572.Figure 27 shows the complete expansion shape of INAS550, and wherein the injection outlet central authorities of port 567 and the far-end of guiding tube 565 579 central authorities approach by distance L 12, and described guiding tube 565 has radiopaque section 572.L12 should be 0.5mm-5mm.

Figure 28 is that described INAS has sheath 512 at the middle body in the cross section at the S28-S28 place of the INAS550 of Figure 27.It shows the non-circular cross sections guiding tube 565 around syringe 566.At S28-S28 place, position, middle pipe 564 is fixedly attached to the outside of three guiding tubes 565 and three line 561A, 561B and 561C, described middle pipe 564 is connected to the guiding tube control cylinder 533 of Figure 26, and described three lines reverse together to become heart yearn 561 as shown in figure 27.This can form connecting media 555 with the intracavity at middle pipe 564 by injection of plastic or binding agent and complete.

Figure 29 is the schematic diagram of the distal part of the another one embodiment of INAS600, described INAS600 has stranded core 611, described stranded core 611 has circular cross section guiding tube 615, and described circular cross section guiding tube 615 has distally radiopaque section 622.

Except stranded core 611 and three instead of 4 entry needles, INAS600 is similar to the INAS500 of Figure 24 slightly.It has containing the sheath 612 of distally radiopaque labelling 613, contains distally entry needle 619 and inject the syringe 616 that exports port 617.It also has the radiopaque line 618 that is positioned at syringe 616, to help manifesting in fluoroscopy process.Tapered distal section 620 has tapered segment 626, radiopaque labelling 624 and proximal section 623.Be similar to the INAS550 of Figure 27 and 28, this embodiment has (nearside) backward curved shape of syringe 616, and described syringe 616 has entry needle 619.Particularly, the radius of curvature of syringe 616 should be mated or be slightly less than the radius of curvature of (more bending) guiding tube 615 and guiding tube distally radiopaque section 622.This will prevent in the time that pin 569 penetrates the wall of target vessel, comprises the stretching of guiding tube 615 of distally radiopaque section 622.

Manifest for better, in Figure 29, the portions of proximal of sheath 612 and middle pipe 614 is shown as transparent, and the internal structure that makes INAS600 is obvious.Particularly, use the technology of the INAS550 that is similar to Figure 28, three circular cross section guiding tubes 615 are connected to middle pipe 614.That also show is line 611A, and described 611A is one of three lines, and described three lines reverse together to form same heart yearn 611 as shown in Figure 27 and 28.Use is similar to the manifold (not shown) of the manifold 410 of Figure 20, and inner tube 606 inside are attached to three syringes 616, and described inner tube 606 is connected to the pin control cylinder 545 of Figure 26.Show and enter the near-end 605 of three guiding tubes 615 syringe 616 when interior when three syringes 616.

Figure 30 is the schematic diagram of the interior section of INAS600, and described INAS600 clearly shows the near-end of radiopaque line 618, and described radiopaque line 618 moves the length of syringe 616, so that radiopacity to be provided.These radiopaque lines 618 are similar to radiopaque line 518 of Figure 24 and 25.Be transparent 606,3 guiding tubes of inner tube 615, three syringes 616,611A and 611B having clearly visible in this interior section that sheath 612 and middle pipe 614 remove, described 611A and 611B are two in the composition line of heart yearn 611 of Figure 29.Manifold 610 is presented at inner tube 606 inside in Figure 30.The distal part that shows manifold 610, wherein portions of proximal is transparent.Although not shown, manifold 610 nearside transparent parts extend to the near-end of syringe 616, are similar to the manifold 410 of Figure 20.Finally, the radiopaque line 618 that leaves the near-end of syringe 616 folds back, and moves backward at the Zhong distally, space on syringe 616 sides longitudinal direction.

As shown in figure 31, described Figure 31 is in the cross section at the S31-S31 place of Figure 30, and manifold 610 is plastics or binding agents of plastotype or injection, and the inside of inner tube 606 and three syringes 616 and three radiopaque lines 618 are sealed.In complete conduit 600, it is not interior section.

Figure 32 A is the schematic diagram of the embodiment of INAS700 distal part, and described INAS700 distal part has non-circular guiding tube 715.What also show is heart yearn 711 and is taper to have ellipse or oval cross-section.Tapered distal section 720 has tapered segment 726, radiopaque labelling 724 and proximal section 723.The far-end of sheath 712 is just in time visible.Guiding tube 715 in this embodiment can be made up of NITINOL or for example polyamide of the plastics that form.The advantage of the non-circular cross sections of guiding tube 715 is: when distally promotes syringe when engaging the inwall of target vessel, be provided for the better support of syringe (not shown).

Figure 32 B is the end on the schematic diagram of INAS700 of Figure 32 A of watching in proximal direction, just in time at the nearside of the near-end of tapered distal section 720.Herein, visible replace be oriented in pure radially in abducent guiding tube 715, guiding tube 715 90-degree rotations are to radially, to allow non-circular cross sections conduit diameter to be had to the impact of minimizing.The far-end of visible heart yearn 711 and sheath 712 in cross section.

Figure 33 is the schematic diagram of the embodiment of proximal section/handle 640 of INAS600, and described INAS600 has the locking mechanism activating by the rotation of sheath control lock 632 and pin control lock 642.Particularly, position shown in 632 anticlockwise Figure 33 of rotating to form is locked in sheath control, until have together with the sheath syringe pipe 636 of Rule port 634 comes with longitudinal slit 631, the motion of release sheath control cylinder 635, described sheath control cylinder 635 is attached to sheath 612 by tapered segment 638.Sheath control cylinder 635 and tapered segment 638 can pull with respect to guiding tube control cylinder 633 in proximal direction now, with as visible in the configuration of Figure 29, sheath are shunk with respect to guiding tube.Once sheath control cylinder 635 retracts in proximal direction always, together with sheath syringe pipe 632 just comes with circumferential slot 633 now, described circumferential slot 633 is extended in the clockwise direction in sheath control lock 632.In this position, sheath control lock also can rotate in the counterclockwise direction, makes sheath syringe pipe 636 be positioned at circumferential slot 633, and prevents the lengthwise movement of sheath control cylinder 635.Imagination spring can embed in this mechanism, once make sheath rinse 636 come with slit 633 together with, sheath control lock 632 plays latched position with regard to appliance for releasing single.

Once sheath 612 shrinks in proximal direction as mentioned above, handle just prepares the syringe with entry needle 619 of Figure 29 616 distally to advance, to penetrate the blood vessel wall of target vessel, and described syringe 616.Circumferential slot 643 is connected by longitudinal slit 641 with 648.Be attached to the outside lock pin 647 of pin control cylinder 645, advance along track three slits 643,641 and 648 are interior, to lock and release guiding tube control cylinder 633 relative motioies with respect to pin control cylinder 645.For the syringe 616 that makes Figure 29 can advance, pin locking cylinder 642 rotates in the clockwise direction, so that pin 647 aligns with longitudinal slit 641.Pin control cylinder 645 can move in distal direction now, impels syringe 616 distally to advance.In the time that pin 647 arrives the position of aliging with circumferential slot 648 now, described pin 647 no longer moves in distal direction, and pin 619 penetrate therefore limited.In this configuration, turning clockwise in addition of cylinder 642 of pin locking moves to pin 647 in circumferential slot 648, the lengthwise movement of described circumferential slot 648 present locking pin control cylinders 645.Syringe can be attached to Rule accessory 654 now, and as required suitable is melted to fluid injecting in all spaces of blood vessel.Now will complete the other injection of saline or other inert fluids, to rinse the inside dead space of INAS600, and guarantee that all fluids that melt are delivered to desired area completely.Sheath 612 shrinks and the reversion of syringe 616 distal movement can complete by the reserve motion of the parts of handle 640 now.

Also imagining proximal section 640 can build like this, and the rightabout rotation of any in above-mentioned steps will be worked.Clearly imagine the combination of rotatablely move (for example, for described in proximal section/handle 640 of Figure 33) and button locking/release mechanism (for example, shown in proximal section/handle 540) herein.

Figure 34 is the guiding tube 815 of another embodiment and the schematic diagram of syringe 816 of INAS800 of the present invention, and described INAS800 has three guiding tubes 815, and described three guiding tubes 815 separate with main traverse main body 813.Each guiding tube 815 has two chambeies, a passage for syringe 816, and another is for the passage of line 818, and described line 818 provides the shape memory that impels guiding tube 815 to open for the blood vessel wall inside of target vessel.Line 818 also can be provided for manifesting the other radiopacity of guiding tube 815.Guiding tube 815 and guiding tube main body 813 in INAS800 are made up of plastic material, and described plastic material is enough soft to allow line 818 to impel shape shown in guiding tube 815 formation.Also imagine guiding tube 815 and self will comprise for example tungsten of radiopaque material or barium.Line 818 can be made up of for example NITNOL of marmem, or is made up of for example spring steel of preform elastomeric material.What also show is the near-end of inner tube 806, and described inner tube 806 is attached to the syringe 816 with far-end, and described far-end has sharp-pointed entry needle 819, and described entry needle 819 has injection outlet 817.

Figure 35 is the schematic diagram of the another one embodiment of INAS900 of the present invention, and described INAS900 has syringe 916, and described syringe 916 has distal needle 919, and described distal needle 919 has injection outlet port 917.INAS900 also has three guiding tubes 915, and described guiding tube 915 is included in the lenticular wire 918 of guiding tube 915 inside.Lenticular wire 918 provides shape memory and optional for manifesting the radiopacity of guiding tube 915.Lenticular wire 918 is generally made up of for example NITINOL of memory metal or for example spring steel of elastomeric material.Guiding tube 915 is generally made up of plastic material, and described plastic material is enough soft to allow line 818 to impel shape shown in guiding tube 815 formation.What also show is sheath 912 and heart yearn 911, and described sheath 912 and heart yearn 911 are similar to those shown in early embodiment many of INAS in function.Also imagine guiding tube 915 and self will comprise for example tungsten of radiopaque material or barium.

Although all having, each in the INAS embodiment showing herein closes and open position, wherein closed position has the entry needle of encapsulation completely, but imagining this system will work together with external jacket, as U.S. Patent number 7,087, shown in 040 McGuckin device, described external jacket is opened at its far-end.In this type of embodiment, by entry needle is drawn back to enough their hiding distances in proximal direction, can prevent needle stick injuries.The motion of the interlocking lockable pin in proximal section and/or handle, accidentally mobile in distal direction to prevent them.This concept will with the INAS design of Fig. 1-10, and those embodiment with the guiding tube shown in Figure 11-35 work together, wherein pin will shrink by nearside in guiding tube, and subsequently guiding tube will be retracted in sheath.

Figure 36 A is the longitudinal cross-section view of another embodiment of the distal part of the syringe 956 of INAS950, and the distal part of described syringe 956 has distally entry needle 959.Other similar of INAS950 are in the INAS10 of Fig. 1.Entry needle 959 has injection outlet 957.Be presented at the stylet 958 of the intracavity portion of syringe 956.Stylet 958 has two potential uses, 1) it can make syringe 956 harden to it will to maintain its suitable curved shape, and penetrate better the inwall of target vessel, and 2) it can be provided for the other radiopacity manifesting in fluoroscopy FAXIA.Also imagine entry needle 959 and can there is non-sharp-pointed end, and extensible injection outlet 957 sharpening of exceeding of stylet 958, so that the instrument of the inwall that penetrates target vessel to be provided.Stylet 958 will take out completely or retract, to do not hinder mobile in the time that pin suitably arranges.The rope 13 of INAS10 of for example Fig. 1 of restricting can provide the instrument that limits penetration depth in this design.

Figure 36 B is the longitudinal cross-section view of the another one embodiment of the distal part of the plastics nearside pipe 965 of INAS950, and described INAS950 has syringe 966, and described syringe 966 has the distally entry needle 969 in the far-end that inserts syringe 965.Radiopacity provides by the radiopaque indicia band 962 on syringe 965 with at radiopaque line 968 of syringe 966 inside.Entry needle 969 has injection outlet 957.Syringe 965 is by for example polyurethane of preform plastics or Methanamide is two-layer or the combination of more multi-layered plastics is made.The far-end 961 of syringe 965 provides the instrument penetrating of restriction pin 969.Also imagining syringe 966 can be made up of for example tantalum of radiopaque metal or L605 cobalt chromium, or syringe 966 can be electroplated or coating by for example gold of radiopaque metal.In these cases, will not need radiopaque line 968.

Figure 36 C is the longitudinal cross-section view of the another one embodiment of the distal part of metal nearside pipe 975, and described metal nearside pipe 975 has syringe 976, and described syringe 976 has the distally entry needle 979 in the far-end that inserts syringe 975.Radiopacity provides by the radiopaque indicia band 972 on syringe 975 with at radiopaque line 978 of syringe 976 inside.Entry needle 979 has injection outlet 977.Syringe 975 is made up of for example NITINOL of preform metal.The far-end 971 of syringe 975 provides the instrument penetrating of restriction pin 979.

Although this description has concentrated on INAS for the purposes at ablation of tissue, but also the apparatus of clear and definite imaginary picture of primitive people 1-33 and method can be applicable to this apparatus and inject the purposes of any fluid for any object, described any object comprises that localized drug delivery arrives the specified portions of blood vessel or just in time in the tissue volume of blood vessel outside.

That yes is possible for multiple other modifications, adaptation and the above-mentioned instruction of alternative design consideration.Therefore, be now to be understood that in the scope of accessory claim, the present invention can from specifically describe other different modes herein and put into practice.

Claims

1. for melting fluid and be delivered to a neural ablation system near the blood vessel of the tissue volume blood vessel wall of target vessel, in described blood vessel, neural ablation system comprises:

Catheter main body, central axis and fluid injecting chamber that described catheter main body has near-end, far-end, extends at longitudinal direction;

At least the first and second guiding tubes, described at least the first and second guiding tubes are positioned at the distally of the described far-end of described catheter main body, each guiding tube has far-end, chamber and distal part, described distal part and the primary importance of described axial alignment and tilt away from the second position of described axis between can be to external expansion;

At least the first and second syringes, each syringe has the injecting cavity that melts the path of fluid described in being provided for sending, described syringe difference coaxial positioning is at the intracavity of described the first and second guiding tubes, each syringe has sharp-pointed entry needle, described entry needle has the injection outlet at its far-end, each syringe be suitable in the intracavity distally of described the first and second guiding tubes with nearside slide; With

Penetration depth limiting mechanism, described penetration depth limiting mechanism is for limiting the penetration depth in the blood vessel wall that described entry needle enters described target vessel.

2. system according to claim 1, described system also comprises sheath, described sheath is fixedly attached near the sheath controlling organization near-end that is positioned described catheter main body, described sheath coaxial positioning is in the outside of described catheter main body, described sheath has closed position and open position, described open position allow described guiding tube for the inside of the wall of described target vessel to external expansion, described closed position encapsulates described guiding tube, syringe and entry needle completely.

3. system according to claim 2, the distal part of wherein said guiding tube is from expansion, and it is described from expansion guiding tube that the expansion of described guiding tube impels the proximal movement of described sheath to discharge, and outwards moves with the central axis from described catheter main body.

4. system according to claim 2, described system also comprises syringe controlling organization, described syringe controlling organization is suitable for controlling in the time that the intracavity of described guiding tube slides when described syringe distally and the proximal movement of described syringe.

5. system according to claim 4, described system also comprises label, to indicate the use order of described sheath controlling organization and described syringe controlling organization, described label is selected from least one in following type: Roman number letter, number, word, arrow or direction thing.

6. system according to claim 1, wherein saidly melts the sending as circular pattern of fluid.

7. system according to claim 1, described system also comprises the port for melting fluid described in injecting, described port is communicated with the fluid injecting chamber fluid of described catheter main body.

8. system according to claim 1, wherein said entry needle is less than 25 specifications.

9. system according to claim 1, described system also comprises at least one radiopaque labelling.

10. system according to claim 9, described system is included in the radiopaque labelling on described sheath.

11. systems according to claim 9, described system is included in the radiopaque labelling at least one in described guiding tube.

12. systems according to claim 1, the wherein said limiting mechanism that penetrates limits described injection outlet near the position blood vessel wall of described target vessel penetrate, and the blood vessel wall of described target vessel is selected from one of following position: middle film, adventitia, adventitia outside, middle film and the adventitia of described target vessel or adventitia and adventitia outside both.

13. 1 kinds for melting fluid and be delivered to neural ablation system near the blood vessel of the tissue volume blood vessel wall of target vessel, and in described blood vessel, neural ablation system comprises:

Catheter main body, central axis and fluid injecting chamber that described catheter main body has near-end, extends at longitudinal direction;

Melt the external source of fluid, described in melt fluid external source be communicated with described fluid injecting chamber fluid;

Guiding tube, described guiding tube has near-end, far-end and chamber, and described guiding tube has and is suitable for abducent distal part;

Syringe, described syringe has the injecting cavity being communicated with the fluid injecting chamber fluid of described catheter main body, a part of coaxial positioning of described syringe is in the inside of described guiding tube, described syringe has sharp-pointed entry needle, described entry needle has the injection outlet at its far-end, the injecting cavity of described syringe is communicated with the fluid injecting chamber fluid of described catheter main body, and described syringe is suitable for sliding in nearside and distal direction at the intracavity of described guiding tube;

Syringe controlling organization, described syringe controlling organization is suitable for controlling described syringe and moves with respect to nearside and the distally of described guiding tube;

Port, described port for inject be positioned near the near-end of described catheter main body described in melt fluid, described port is communicated with the fluid injecting chamber fluid of described catheter main body;

And, penetration depth limiting mechanism, described penetration depth limiting mechanism exports the penetration depth in the blood vessel wall that enters target vessel for limiting described entry needle injection.

14. systems according to claim 13, described system also comprises sheath, described sheath has the sheath controlling organization in its proximal end, described sheath coaxial positioning is in the outside of described catheter main body, described sheath has closed position and open position, described open position allows described guiding tube and described syringe to external expansion, be delivered to the wall of described target vessel to be conducive to melting fluid, described sheath controlling organization is suitable for controlling described sheath and cuts out the lengthwise movement between open position at it.

15. systems according to claim 14; described guiding tube and the encapsulation completely in the injection outlet of the described far-end of described entry needle are impelled in the closed position of wherein said sheath; in the process of inserting described target vessel and take out from described target vessel; described closed position provides the protection not completely being subject to from the involuntary release of the fluid in described system chamber, and described closed position also prevents for using the patient of described system or the damage of medical personnel's accidental needle sticks.

16. nervus vasculairs ablation systems according to claim 15, described nervus vasculairs ablation system also comprises tapered distal part, when described sheath is during in its closed position, described tapered distal part and the combination of described sheath encapsulate described entry needle completely.

17. systems according to claim 14, described system is also included near the radiopaque labelling of far-end of described sheath.

18. systems according to claim 14, described system also comprises locking mechanism, described locking mechanism prevents the lengthwise movement of described sheath in the time engaging.

19. nervus vasculairs ablation systems according to claim 13, wherein saidly melt the sending as helicon mode of material.

20. nervus vasculairs ablation systems according to claim 13, described nervus vasculairs ablation system also comprises and prevents the parts of described syringe with respect to the movement of described guiding tube.

21. systems according to claim 20, described system also comprises near the handle near-end that is positioned described catheter main body, described handle is the parts that prevent the movement of the described syringe of integrating with described handle.

22. systems according to claim 13, wherein saidly melt sending of fluid and enter at least one the particular organization's volume being selected from following: the volume of the volume of the adventitia outside of the adventitia of the wall of the middle film of the wall of described target vessel, described target vessel, the wall of described target vessel, the middle film of the wall of described target vessel and the adventitia of adventitia and described target vessel and adventitia outside.

23. systems according to claim 13, wherein saidly melt sending of fluid and comprise that at least three inject stomion.

24. systems according to claim 13, wherein said catheter main body comprises the fixing cord that is attached to its far-end.

25. systems according to claim 13, described system is formed on wire separately and coaxially advances.

26. systems according to claim 13, the distal part of wherein said syringe is from expansion.

27. systems according to claim 26, are wherein saidly formed by NITINOL from expansion.

28. systems according to claim 13, the wherein said fluid that melts comprises being selected from and melts at least one in fluid described in following: ethanol, phenol, glycerol, lignocaine, bupivacaine, tetracaine, benzocaine, guanethidine, botulinum toxin, distilled water, hypotonic saline solution or hypertonic saline solution.

29. systems according to claim 13, the wherein said fluid that melts is the fluid composition heating.

30. nervus vasculairs ablation systems according to claim 13, the wherein said fluid that melts is cooling fluid composition.

31. nervus vasculairs ablation systems according to claim 13, the wherein said fluid that melts is by the vapor form of the injecting cavity injection of described catheter main body.

32. systems according to claim 13, described syringe controlling organization and described penetration depth limiting mechanism are positioned in proximal handle.

33. 1 kinds of transdermal delivery systems of sending for blood vessel Zhou Liuti, described transdermal delivery system comprises:

Fluid delivery catheter, described fluid delivery catheter has nearside control section, center conduit main body, distally fluid and sends part;

Described distally fluid delivery portion is divided and is comprised the 2 or more entry needles with chamber, described entry needle has near the injection outlet its far-end, described pin is also suitable for radially outward moving, to penetrate the wall of target vessel, so that described injection outlet is arranged on to the preset degree of depth with respect to the inwall of described target vessel;

Described nearside control section comprises proximal port and the controlling organization for injecting fluid, and described controlling organization is suitable for impelling the outward radial motion of described entry needle;

Described center conduit main body comprises injecting cavity, described injecting cavity provides the fluid between described proximal port and the chamber of described entry needle for injecting fluid to be communicated with, described middle body also comprises the member of the outward radial motion that allows described nearside controlling organization to impel described entry needle

Described fluid delivery catheter also comprises internal fluid volume, described internal fluid volume comprises the internal fluid volume that the near-end of the proximal port from described nearside control section of described conduit exports to the injection of the far-end at described entry needle, and described internal fluid volume is less than 0.5ml.

34. systems according to claim 33, the internal fluid volume of wherein said fluid delivery catheter is less than 0.2ml.

35. systems according to claim 33, the internal fluid volume of wherein said fluid delivery catheter is less than 0.1ml.

36. systems according to claim 33, at least one in the chamber of wherein said entry needle comprises that volume occupies structure.

37. systems according to claim 36, wherein said volume occupies structure and comprises the line that is configured to reduce described internal fluid volume.

38. according to the system described in claim 37, and wherein said line is formed by radiopaque material, to strengthen described entry needle manifesting in fluoroscopy FAXIA.

39. 1 kinds of transdermal delivery systems of sending for blood vessel Zhou Liuti, described transdermal delivery system comprises:

Described entry needle also comprises and is designed to provide the structure of described entry needle in the enhancing visibility of fluoroscopy FAXIA.

40. according to the system described in claim 39, and at least a portion of at least one in wherein said structure comprises radiopaque material.

41. according to the system described in claim 40, and wherein said radiopaque material comprises at least one in tantalum, platinum and gold.

42. according to the system described in claim 40, and at least one in the chamber of wherein said entry needle comprises radiopaque line.

43. according to the system described in claim 40, and at least a portion of wherein said entry needle comprises at least one in radiopaque band, ring, implant, insert, plug and coating.

44. 1 kinds of transdermal delivery systems of sending for blood vessel Zhou Liuti, described transdermal delivery system comprises:

Described distally fluid delivery portion is divided and is comprised 2 or more extendible guiding tube, each guiding tube has far-end and chamber, described distally fluid is sent part and is also comprised the 2 or more entry needles with injecting cavity, every entry needle is suitable for moving at intracavity distally and the nearside of described guiding tube, every needle set has near the injection outlet its far-end, described pin is also suitable for the outwards preset distance of the mobile far-end that exceeds described guiding tube of distally, to penetrate the wall of target vessel, so that described injection outlet is arranged on to the preset degree of depth with respect to the inwall of described target vessel;

Described nearside control section comprises proximal port and the mechanism for injecting fluid, described mechanism is suitable for impelling distally and the proximal movement of described entry needle, described mechanism is also suitable for limiting described injection outlet and penetrates into the preset degree of depth with respect to the inwall of described target vessel, described nearside control section also comprises internal mechanism, so that the preset distance that penetrates the inwall that exceeds described target vessel about described injection outlet to be set;

Described center conduit main body comprises injecting cavity, described injecting cavity provides the fluid between described proximal port and the chamber of described entry needle for injecting fluid to be communicated with, and described middle body also comprises that the described nearside controlling organization of permission impels the distally of described entry needle and the member of proximal movement.

45. according to the system described in claim 44, and the described internal mechanism that described preset distance is wherein set is to approach for the user of described system.

46. according to the system described in claim 44, the described internal mechanism of described preset distance is wherein set for proofread and correct described preset distance in manufacture process, and described internal mechanism is hidden for the user of described system.

47. 1 kinds of transdermal delivery systems of sending for blood vessel Zhou Liuti, described transdermal delivery system comprises:

Described distally fluid is sent part and is had movable part, described movable part comprises external jacket, 2 or more extendible guiding tube, each guiding tube has far-end and chamber, described fluid is sent part and is also comprised 2 or the more syringe with distally entry needle, described syringe and entry needle have injecting cavity, each syringe is suitable for moving at intracavity distally and the nearside of described guiding tube, every entry needle has near the injection outlet its far-end, every pin is also suitable for the outwards preset distance of the mobile far-end that exceeds described guiding tube of distally, to penetrate the wall of target vessel, and described injection outlet is arranged on to the preset degree of depth with respect to the inwall of described target vessel, described distally fluid is sent part and is also comprised the external jacket with closed position and open position, described open position is positioned at the far-end of described sheath the preset distance of the nearside of the described remote location of described sheath in the closed position,

Described nearside control section comprises the proximal port for injecting fluid, entry needle controlling organization and sheath controlling organization, described entry needle controlling organization is suitable for impelling the syringe with distally entry needle with respect to distally and the proximal movement of described guiding tube, described sheath controlling organization is suitable for impelling distally and the proximal movement of described external jacket between its closed position and open position thereof, described nearside control section is also suitable for limiting described injection outlet and penetrates into the preset degree of depth with respect to the inwall of described target vessel, described nearside control section also comprises the mechanism that adjusts described preset distance, described nearside control section has at least one locking mechanism, send at least one the motion in the movable part of part to prevent described distally fluid,

Described center conduit main body comprises inner tube and sheath, described inner tube is coaxially positioned at described sheath, described inner tube has injecting cavity, described injecting cavity provides the fluid between described proximal port and the chamber of described syringe for injecting fluid to be communicated with, the chamber of described syringe is communicated with the chamber fluid of described entry needle, described inner tube is also provided for the instrument of entry needle controlling organization, to impel the syringe with distally entry needle with respect to distally and the proximal movement of described guiding tube.

48. according to the system described in claim 47, and wherein said nearside control section comprises locking mechanism, and described locking mechanism is configured to prevent that described sheath from moving with respect to distally and the nearside of described guiding tube.

49. according to the system described in claim 47, and wherein said nearside control section comprises locking mechanism, and described locking mechanism is configured to prevent that described syringe from moving with respect to distally and the nearside of described guiding tube.

50. according to the system described in claim 47, wherein said nearside control section comprises mutual interlocking gear, if described mutual interlocking gear is configured to described distally fluid and sends at least one in the movable part of part in undesirable state, prevent that described distally fluid from sending another the motion in the movable part of part.

51. according to the system described in claim 50, and wherein said nearside control section comprises mutual interlocking gear, unless described mutual interlocking gear is configured to described entry needle completely at the intracavity of described guiding tube, otherwise prevents that described external jacket from moving to its closed position.

52. according to the system described in claim 50, and wherein said nearside control section comprises mutual interlocking gear, unless described mutual interlocking gear is configured to described external jacket in its open position, otherwise prevents distally and the proximal movement of described syringe.

53. 1 kinds of transdermal delivery systems for sending in the blood vessel week of fluid, described transdermal delivery system comprises:

Fluid delivery catheter, described fluid delivery catheter has longitudinal axis, nearside control section, center conduit main body, distally fluid and sends part and the container about injecting fluid;

Described distally fluid is sent part and is had movable part, described movable part comprises 2 or more extendible guiding tube, each guiding tube has chamber and has central far-end, described movable part also comprises 2 or the more syringe with distally entry needle, described syringe and entry needle have injecting cavity, each syringe is suitable for moving at intracavity distally and the nearside of described guiding tube, every entry needle has near the injection outlet its far-end, described pin is also suitable for radially outward moving to the position of launching completely, to penetrate the wall of target vessel, so that described injection outlet is arranged on to the preset degree of depth with respect to the inwall of described target vessel, the described syringe with distally entry needle has curved shape, when described pin in completely launch position time, described curved shape impels at least one injection outlet of described entry needle bending after nearside longitudinal direction is with respect to the mediad of the far-end of described guiding tube,

Described center conduit main body comprises injecting cavity, described injecting cavity provides the fluid between described proximal port and the chamber of described syringe for injecting fluid to be communicated with, and described middle body also comprises the member of the outward radial motion that allows described nearside controlling organization to impel described entry needle.

54. according to the system described in claim 53, the distal part of wherein said guiding tube has guiding tube radius of curvature, and the distal part that comprises the described syringe of entry needle has pin radius of curvature, in the time that described guiding tube is expanded completely, described guiding tube radius of curvature and described pin radius of curvature are roughly the same.

55. 1 kinds for being delivered to given fluid the outside fluid delivery system of the blood vessel wall of human body target blood vessel or the blood vessel wall of human body target blood vessel, and described fluid delivery system comprises:

Catheter main body, described catheter main body has the central axis extending at longitudinal direction, described catheter main body has fluid injecting chamber, described fluid injecting chamber is communicated with three or the sharp entry needle fluid of more tips of a root, described catheter main body also comprises distal tip and external jacket, described external jacket has wherein said sheath and encapsulates together with described distal tip the first closed position of described sharp-pointed entry needle, described sheath has the second open position, and described open position allows described entry needle to enter to external expansion in the blood vessel wall of target vessel;

External source of fluid and injection outlet, described external source of fluid is communicated with described fluid injecting chamber fluid, described injection outlet is positioned near the far-end of described pin, and described pin is suitable for providing from the circumference that melts fluid described in described fluid injecting chamber and sending in the injection depth of specifying.

56. according to the system described in claim 55, wherein described fluid is delivered to and is selected from following particular organization's volume:

The middle film of the wall of described target vessel,

The adventitia of the wall of described target vessel,

The volume of the adventitia outside of the wall of described target vessel,

Middle film and the adventitia of the wall of described target vessel, and

The volume of the adventitia of described target vessel and adventitia outside.

57. according to the system described in claim 55, and wherein said sending comprises that at least three inject stomion.

58. according to the system described in claim 55, and described system also comprises distally air bag, flows in described target vessel middle and lower reaches to melt fluid described in preventing.

59. according to the system described in claim 55, and wherein said catheter main body comprises the fixing cord that is attached to its far-end.

60. according to the system described in claim 55, and described system is formed on wire separately and coaxially advances.

61. according to the system described in claim 55, and wherein said injection outlet is provided by least one syringe, and described syringe has the entry needle at its far-end, and described injection exports near the far-end of described entry needle.

62. according to the system described in claim 55, and described system also comprises that distally is from expansion.

63. according to the system described in claim 62, and wherein said distally comprises described injection outlet from expansion.

64. according to the system described in claim 63, wherein said distally comprises at least one guiding tube from expansion, and described injection outlet is provided by least one syringe, described syringe has the pin at its far-end, and described at least one syringe is suitable for being advanced and being shunk by described at least one guiding tube.

65. according to the system described in claim 63, and described system also comprises sheath, when described jacket shrinkage is during to the open position of its recent side, allow described distally from expansion to external expansion.

66. according to the system described in claim 62, is wherein saidly formed by NITINOL from expansion.

67. according to the system described in claim 55, and wherein said sheath is included near the radiopaque labelling its far-end.

68. according to the system described in claim 55, and wherein said distal tip comprises radiopaque labelling.

69. according to the system described in claim 55, and wherein said fluid comprises at least one being selected from following described fluid: chemotherapeutant, alcohol, ethanol, phenol, glycerol, lignocaine, bupivacaine, tetracaine, benzocaine, distilled water, hypertonic saline, hypotonic saline, guanethidine and botulinum toxin.

70. according to the system described in claim 55, and the wherein said fluid that melts is the fluid composition heating.

71. according to the system described in claim 55, and the wherein said fluid that melts is cooling fluid composition.

72. according to the system described in claim 55, and the wherein said fluid that melts is by the vapor form of the injecting cavity injection of described catheter main body.